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Since November 2022, an indefinite pause of study activities caused by a hospital-wide shortage of esophageal balloons has persisted for almost a full year with an indefinite resupply date. Thus, the PI has opted to close to any further enrollment.
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| Name | Class |
|---|---|
| East Carolina University | OTHER |
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This is a research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator.
Participants will have catheter placed through the nose into the esophagus to measure the pressure inside the chest. This catheter will remain until the patient is freed from the ventilator. Participants will be randomized to usual care or to have the level of PEEP determined by the esophageal balloon pressure readings. The total time spent on the ventilator will be recorded.
Study Design:
Randomized-controlled clinical trial. Patients will be enrolled within 4 days of mechanical ventilation and randomized 1:1 to titration of PEEP based on esophageal balloon pressures or based on the "High PEEP" ARDSnet PEEP/fraction of inspired oxygen (FiO2) table. All patients will have esophageal balloons placed with baseline measurement of Ptp. Patients randomized to the intervention arm will then undergo titration of PEEP based on Ptp measurements to achieve "Optimal PEEP," defined as end expiratory Ptp of 0 to +2 cm water (H2O).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimal PEEP | Experimental | The waveforms of airway pressure (Paw), esophageal pressure (Pes), and transpulmonary pressure (Ptp) will be visualized on the ventilator. Ptp is obtained from Paw - Pes. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP). Measurements will be obtained daily and adjustments to PEEP will occur daily. PEEP will be reduced below Optimal PEEP in the setting of hemodynamic compromise (requiring increasing vasoactive medications for blood pressure support). |
|
| Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP | Active Comparator | PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2. The investigators chose the High PEEP table based on the clinical suspicion that obese patients may require higher PEEP levels on average than non-obese patients to balance the additional pressure of their chest wall. In addition, EPVent2, a study of esophageal balloon PEEP titration in patients with ARDS utilized the High PEEP table. Patients with moderate and severe ARDS benefit from higher levels of PEEP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophageal balloon | Device | All patients in both groups will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into their nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Ventilator-Free Days (VFD) by Day 28 | The number of days a patient is alive and free from the ventilator up to day 28. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reintubated | Intubated within 72 hours of extubation | 72 hours after extubation |
| ICU Length of Stay | Number of days spent in the ICU |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon Carson, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States | ||
| East Carolina University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30245572 | Background | Obi ON, Mazer M, Bangley C, Kassabo Z, Saadah K, Trainor W, Stephens K, Rice PL, Shaw R. Obesity and Weaning from Mechanical Ventilation-An Exploratory Study. Clin Med Insights Circ Respir Pulm Med. 2018 Sep 18;12:1179548418801004. doi: 10.1177/1179548418801004. eCollection 2018. | |
| 30776290 | Background | Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555. |
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A deidentified dataset will be available to investigators 9-36 months following publication of the study.
Beginning 9 to 36 months following publication
Data can be obtained upon application to primary investigators. Investigators who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and execute a data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | Optimal Post End Expiratory Pressure (PEEP) | Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. Mechanical ventilation settings were monitored daily and Post End Expiratory Pressure (PEEP) setting adjusted based on the balloon measurements. Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Intervention Spontaneous Breathing Trial (SBT) and Extubation: Participants undergo an SBT regardless of PEEP level. The PEEP that generates a Ptp of 0 was considered the optimal PEEP, and this will not be lowered for the SBT. The Intervention Group SBT will consist of a trial of a pressure support of 5 cm water (H2O) and Optimal PEEP. Intervention Weaning after Tracheostomy: Based on the use of optimal PEEP in this group and the experience in the previous study protocol, the investigators will place participants in the Intervention group on Tracheostomy Collar Trial only with a speaking valve. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2021 |
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Due to the obvious treatment differences between the two groups, blinding of treatment group will be impossible. However, the investigators will have one outcome assessor who will have access only to the data necessary to determine the primary outcome (Ventilator-Free Days at 28-days), and this assessor will be blinded to treatment group using built-in REDCap tools.
|
| Intervention Spontaneous Breathing Trial (SBT) and Extubation | Procedure | Patients in the Intervention group will undergo an SBT regardless of their PEEP level. The PEEP that generates a Ptp of 0 will be considered their optimal PEEP, and this will not be lowered for the SBT. The Intervention Group SBT will consist of a trial of a pressure support of 5 cm H2O and Optimal PEEP. |
|
| Control Spontaneous Breathing Trial and Extubation | Procedure | Patients in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. This is the current standard of care based on the SBT protocol at UNC Hospitals. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. |
|
| Intervention Weaning after Tracheostomy | Procedure | Based on the use of optimal PEEP in this group, and the experience in the previous study protocol, the investigators will place patients in the Intervention group on Tracheostomy Collar Trial only with a speaking valve. This simulates the normal process of utilizing the upper airway to maintain lung inflation that is performed automatically when a patient does not have an artificial airway. |
|
| Control Weaning after Tracheostomy | Procedure | The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. |
|
| maximum duration of ICU stay, up to 46 days |
| Hospital Length of Stay | Number of days spent in the Hospital | maximum duration of hospital stay, up to 83 days |
| Number of Patients Receiving a Tracheostomy | Whether the patient required a tracheostomy to be liberated from the ventilator | during mechanical ventilation, up to 28 days |
| Number of Patients Extubated Early | Extubation prior to meeting established criteria (Control group only). Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. This is the current standard of care based on the SBT protocol at UNC Hospitals. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. | 28 days |
| Highest Richmond Agitation and Sedation Scale | Measures the mental and physical state of a sedated patient. Range from -5 to +4. A score of 0 indicates a calm arousable patient and is the ideal score. A score of +4 indicates a very combative participant and a score of -5 indicates an unarousable participant. This outcome captures the highest score measured throughout mechanical ventilation with scores on the extreme ends of the range reflecting a worse outcome. | during mechanical ventilation, up to 28 days |
| Lowest Richmond Agitation and Sedation Scale | Measures the mental and physical state of a sedated patient. Range from -5 to +4. A score of 0 indicates a calm arousable patient and is the ideal score. A score of +4 indicates a very combative participant and a score of -5 indicates an unarousable participant. This outcome captures the lowest score measured throughout mechanical ventilation with scores on the extreme ends of the range reflecting a worse outcome. | during mechanical ventilation, up to 28 days |
| Greenville |
| North Carolina |
| 27834 |
| United States |
| FG001 | ARDSNet High PEEP | Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and fraction of inspired oxygen (FiO2) Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Control Spontaneous Breathing Trial and Extubation: Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. Control Weaning after Tracheostomy: The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Optimal PEEP | Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. Mechanical ventilation settings were monitored daily and PEEP setting adjusted based on the balloon measurements. Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Intervention Spontaneous Breathing Trial (SBT) and Extubation: Participants undergo an SBT regardless of PEEP level. The PEEP that generates a Ptp of 0 was considered the optimal PEEP, and this will not be lowered for the SBT. The Intervention Group SBT will consist of a trial of a pressure support of 5 cm H2O and Optimal PEEP. Intervention Weaning after Tracheostomy: Based on the use of optimal PEEP in this group, and the experience in the previous study protocol, the investigators will place participants in the Intervention group on Tracheostomy Collar Trial only with a speaking valve. This simulates the normal process of utilizing the upper airway to maintain lung inflation that is performed automatically when a participant does not have an artificial airway. |
| BG001 | ARDSNet High PEEP | Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2 Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Control Spontaneous Breathing Trial and Extubation: Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. Control Weaning after Tracheostomy: The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Ventilator-Free Days (VFD) by Day 28 | The number of days a patient is alive and free from the ventilator up to day 28. | Posted | Mean | Standard Deviation | Days | 28 days |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants Reintubated | Intubated within 72 hours of extubation | Posted | Count of Participants | Participants | 72 hours after extubation |
| ||||||||||||||||||||||||||||||||
| Secondary | ICU Length of Stay | Number of days spent in the ICU | Posted | Mean | Standard Deviation | Days | maximum duration of ICU stay, up to 46 days |
| |||||||||||||||||||||||||||||||
| Secondary | Hospital Length of Stay | Number of days spent in the Hospital | Posted | Mean | Standard Deviation | Days | maximum duration of hospital stay, up to 83 days |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Patients Receiving a Tracheostomy | Whether the patient required a tracheostomy to be liberated from the ventilator | Posted | Count of Participants | Participants | during mechanical ventilation, up to 28 days |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Extubated Early | Extubation prior to meeting established criteria (Control group only). Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. This is the current standard of care based on the SBT protocol at UNC Hospitals. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. | This measure only applies to the Control group. These data were not collected for the Optimal PEEP arm. | Posted | Count of Participants | Participants | 28 days |
| |||||||||||||||||||||||||||||||
| Secondary | Highest Richmond Agitation and Sedation Scale | Measures the mental and physical state of a sedated patient. Range from -5 to +4. A score of 0 indicates a calm arousable patient and is the ideal score. A score of +4 indicates a very combative participant and a score of -5 indicates an unarousable participant. This outcome captures the highest score measured throughout mechanical ventilation with scores on the extreme ends of the range reflecting a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | during mechanical ventilation, up to 28 days |
| |||||||||||||||||||||||||||||||
| Secondary | Lowest Richmond Agitation and Sedation Scale | Measures the mental and physical state of a sedated patient. Range from -5 to +4. A score of 0 indicates a calm arousable patient and is the ideal score. A score of +4 indicates a very combative participant and a score of -5 indicates an unarousable participant. This outcome captures the lowest score measured throughout mechanical ventilation with scores on the extreme ends of the range reflecting a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | during mechanical ventilation, up to 28 days |
|
From the time of signing the informed consent through 28 days of mechanical ventilation or successful extubation (whichever occurred first).
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Optimal PEEP | Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. Mechanical ventilation settings were monitored daily and PEEP setting adjusted based on the balloon measurements. Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Intervention Spontaneous Breathing Trial (SBT) and Extubation: Participants undergo an SBT regardless of PEEP level. The PEEP that generates a Ptp of 0 was considered the optimal PEEP, and this will not be lowered for the SBT. The Intervention Group SBT will consist of a trial of a pressure support of 5 cm H2O and Optimal PEEP. Intervention Weaning after Tracheostomy: Based on the use of optimal PEEP in this group, and the experience in the previous study protocol, the investigators will place participants in the Intervention group on Tracheostomy Collar Trial only with a speaking valve. This simulates the normal process of utilizing the upper airway to maintain lung inflation that is performed automatically when a participant does not have an artificial airway. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG001 | ARDSNet High PEEP | Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2 Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Control Spontaneous Breathing Trial and Extubation: Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. Control Weaning after Tracheostomy: The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. | 1 | 3 | 0 | 3 | 1 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Emphysema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Diagnosed during study |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Elevated creatinine kinase | Renal and urinary disorders | Systematic Assessment |
| ||
| Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrush | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jackson Pettee | University of North Carolina at Chapel Hill | 984-215-6872 | jackson_pettee@med.unc.edu |
| Mar 18, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D055397 | Ventilator-Induced Lung Injury |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015610 | Serum Bactericidal Test |
| D060666 | Airway Extubation |
| ID | Term |
|---|---|
| D008826 | Microbial Sensitivity Tests |
| D008828 | Microbiological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D004353 | Drug Evaluation, Preclinical |
| D005069 | Evaluation Studies as Topic |
| D058109 | Airway Management |
| D013812 | Therapeutics |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 |
| ARDSNet High PEEP |
Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2 Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Control Spontaneous Breathing Trial and Extubation: Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. Control Weaning after Tracheostomy: The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. |
|
|
| ARDSNet High PEEP |
Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2 Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Control Spontaneous Breathing Trial and Extubation: Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. Control Weaning after Tracheostomy: The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. |
|
|
| OG001 |
| ARDSNet High PEEP |
Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2 Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Control Spontaneous Breathing Trial and Extubation: Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. Control Weaning after Tracheostomy: The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. |
|
|
| OG001 | ARDSNet High PEEP | Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2 Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Control Spontaneous Breathing Trial and Extubation: Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. Control Weaning after Tracheostomy: The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. |
|
|
| OG001 | ARDSNet High PEEP | Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2 Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Control Spontaneous Breathing Trial and Extubation: Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. Control Weaning after Tracheostomy: The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. |
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| OG001 | ARDSNet High PEEP | Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2 Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Control Spontaneous Breathing Trial and Extubation: Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. Control Weaning after Tracheostomy: The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. |
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| OG001 | ARDSNet High PEEP | Obese adult participants presenting to the ICU with acute respiratory failure requiring mechanical ventilation were enrolled. PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2 Esophageal balloon: Participants will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into the nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Placement confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the nasal opening using tape. Control Spontaneous Breathing Trial and Extubation: Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking. Control Weaning after Tracheostomy: The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group. |
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