Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Doctors follow a standard ventilator management strategy when making adjustments to the breathing machine to optimize the amount of oxygen into the lungs. The purpose of this study is to assess whether the EIT (electrical impedance tomography) device can be an additional useful tool for ventilator management and identifying the ideal positive end-expiratory pressure (PEEP).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care then PEEP titration by Electrical Impedance Tomography (EIT) | Experimental | Patients in the usual care first group will continue to receive mechanical ventilation according to the University of Michigan Acute Respiratory Distress Syndrome (ARDS) protocol high-PEEP arm |
|
| PEEP titration by EIT then usual care | Experimental | Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Other | Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical Power | Mechanical power (MP) is the energy imparted to the lung from the mechanical ventilator. It is calculated as listed below, where respiratory rate = RR, tidal volume = TV, Ppeak = peak airway pressure, Pplat = plateau airway pressure and PEEP = positive end-expiratory pressure. Mechanical power determined for the difference between Treatment 1 and Treatment 2. Values shown represent data gathered at the end of the designated assignment listed below, regardless of whether that assignment was Treatment 1 or Treatment 2. MP = 0.098 X RR X TV (Ppeak-[Pplat-PEEP/2]) | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lung Inflammation as Measured by Physiologic Parameter: Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen (P/F Ratio) | P/F ratio is a measurement of oxygenation and, where arterial oxygen in mmHg is PaO2 and percentage of inspired oxygen is FiO2. It calculated as: PaO2/FiO2. P/F ratio determined for the difference between Intervention 1 and Intervention 2 | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment. |
Not provided
Inclusion Criteria:
ii. bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules iii. respiratory failure not fully explained by cardiac failure or fluid overload
-All criteria listed in (3) developed within 1 week of a known clinical insult or new or worsening respiratory symptoms
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Hyzy, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36650593 | Derived | Jimenez JV, Munroe E, Weirauch AJ, Fiorino K, Culter CA, Nelson K, Labaki WW, Choi PJ, Co I, Standiford TJ, Prescott HC, Hyzy RC. Electric impedance tomography-guided PEEP titration reduces mechanical power in ARDS: a randomized crossover pilot trial. Crit Care. 2023 Jan 17;27(1):21. doi: 10.1186/s13054-023-04315-x. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care Then Positive End-Expiratory Pressure (PEEP) Titration by EIT | Patients in the usual care first group will continue to receive mechanical ventilation according to the University of Michigan Acute Respiratory Distress Syndrome (ARDS) protocol high-PEEP arm. Usual care: Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine. PEEP titration by Electrical Impedance Tomography (EIT): PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP). |
| FG001 | Positive End-Expiratory Pressure (PEEP) Titration by EIT Then Usual Care | Patients in the high PEEP titration by Electrical Impedance Tomography (EIT) first will have receive ventilation with a PEEP determined by EIT titration procedure. Usual care: Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine. PEEP titration by EIT: PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization-Intervention 1 (~6 Hrs) |
|
| ||||||||||||||||||||||||
| Intervention 2 (14-18 Hours) |
|
16 participants were randomized, 8 to each arm. 1 participant was removed because of physician's decision, while 3 were removed because of prone positioning. The 4 excluded participants are represented in the Excluded arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Then PEEP Titration by EIT | Patients in the usual care first group will continue to receive mechanical ventilation according to the University of Michigan ARDS protocol high-PEEP arm Usual care: Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine. PEEP titration by EIT: PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Mechanical Power | Mechanical power (MP) is the energy imparted to the lung from the mechanical ventilator. It is calculated as listed below, where respiratory rate = RR, tidal volume = TV, Ppeak = peak airway pressure, Pplat = plateau airway pressure and PEEP = positive end-expiratory pressure. Mechanical power determined for the difference between Treatment 1 and Treatment 2. Values shown represent data gathered at the end of the designated assignment listed below, regardless of whether that assignment was Treatment 1 or Treatment 2. MP = 0.098 X RR X TV (Ppeak-[Pplat-PEEP/2]) | 3 participants in whom prone ventilation was initiated were excluded. 1 additional participant was excluded due to physician withdrawal from the trial. The remaining participants received invasive mechanical ventilation in the supine position for the duration of the protocol. | Posted | Mean | Standard Deviation | J/min | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment. |
|
24 hours
Not provided
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 | Usual Care | Usual care: Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Hyzy, MD | Michigan Medicine | 734-936-5201 | rhyzy@med.umich.edu |
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 | Jan 16, 2020 | Jun 14, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PEEP titration by EIT | Device | PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP). |
|
|
| Change in Lung Inflammation as Measured by Physiologic Parameter: Plateau Pressure | Plateau pressure is a measurement of lung compliance and is the airway pressure obtained during a brief inspiratory hold after delivering a tidal volume breath during invasive mechanical ventilation. Plateau pressure determined for the difference between Intervention 1 and Intervention 2 | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment. |
| Lung Inflammation as Measured by Physiologic Parameter: Driving Pressure | Driving pressure is the force of airway push into the lung while receiving invasive mechanical ventilation and is calculated as Plateau pressure - Positive end-expiratory pressure. Driving pressure determined for the difference between Intervention 1 and Intervention 2 | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment. |
| Change in Lung Inflammation as Measured by Physiologic Parameter: Static Compliance | Static lung compliance is a measurement of lung stiffness due to disease, with a lower compliance representing stiffer lungs. It is calculated as: Tidal volume / (Plateau pressure - PEEP). Static compliance determined for the difference between Intervention 1 and Intervention 2 | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment. |
| Partial Pressure of Arterial Oxygen (PaO2) | PaO2 is the partial pressure of arterial oxygen measured in mmHg. PaO2 determined for the difference between Intervention 1 and Intervention 2. | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment. |
| Dynamic Compliance (Cdyn) | Dynamic compliance is a measurement of the resistance of the lungs and airways to gas installation from the mechanical ventilator and is measured as Peak airway pressure / Plateau airway pressure - PEEP). Dynamic compliance determined for the difference between Intervention 1 and Intervention 2. | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment. |
| Change in Compliance Over the Last 20% of Inspiration (C20/Dyn) | C20 is the compliance that results when only the upper 20% of the applied pressure range is taken into account. The C20/Dyn ratio appears to effectively quantitate evidence of lung over distention during mechanical ventilation. This is a unit-less measure as both numerator and denominator are measured in cm water. C20/dyn determined for the difference between Intervention 1 and Intervention 2. | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment. |
| Ultrasound Surrogates of Lung Aeration | Lung ultrasound inflation scores are calculated by summing regional scores (0-3 points), with higher scores indicating worse condition of the lung. Scores were obtained in six regions of each lung (i.e., up and down anterior, medial, and posterior chest wall). This is a unit-less measure. Ultrasound lung surrogates of lung inflation determined for the difference between Intervention 1 and Intervention 2. | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment. |
| NOT COMPLETED |
|
| BG001 | PEEP Titration by EIT Then Usual Care | Patients in the high PEEP titration by EIT first will have receive ventilation with a PEEP determined by EIT titration procedure. Usual care: Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine. PEEP titration by EIT: PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP). |
| BG002 | Excluded | Patients in this arm were excluded per protocol. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| 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 |
|
| Description |
|---|
| OG000 | PEEP | PEEP titration by EIT: PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP). |
| OG001 | Usual Care | Usual care: Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine. |
|
|
|
| Secondary | Change in Lung Inflammation as Measured by Physiologic Parameter: Partial Pressure of Arterial Oxygen/Fraction of Inspired Oxygen (P/F Ratio) | P/F ratio is a measurement of oxygenation and, where arterial oxygen in mmHg is PaO2 and percentage of inspired oxygen is FiO2. It calculated as: PaO2/FiO2. P/F ratio determined for the difference between Intervention 1 and Intervention 2 | Posted | Mean | Standard Deviation | ratio | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment. |
|
|
|
|
| Secondary | Change in Lung Inflammation as Measured by Physiologic Parameter: Plateau Pressure | Plateau pressure is a measurement of lung compliance and is the airway pressure obtained during a brief inspiratory hold after delivering a tidal volume breath during invasive mechanical ventilation. Plateau pressure determined for the difference between Intervention 1 and Intervention 2 | Posted | Mean | Standard Deviation | cm H2O | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment. |
|
|
|
|
| Secondary | Lung Inflammation as Measured by Physiologic Parameter: Driving Pressure | Driving pressure is the force of airway push into the lung while receiving invasive mechanical ventilation and is calculated as Plateau pressure - Positive end-expiratory pressure. Driving pressure determined for the difference between Intervention 1 and Intervention 2 | ARDS patients | Posted | Mean | Standard Deviation | cm H2O | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment. |
|
|
|
|
| Secondary | Change in Lung Inflammation as Measured by Physiologic Parameter: Static Compliance | Static lung compliance is a measurement of lung stiffness due to disease, with a lower compliance representing stiffer lungs. It is calculated as: Tidal volume / (Plateau pressure - PEEP). Static compliance determined for the difference between Intervention 1 and Intervention 2 | Posted | Mean | Standard Deviation | ml/cm H2O | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment. |
|
|
|
|
| Secondary | Partial Pressure of Arterial Oxygen (PaO2) | PaO2 is the partial pressure of arterial oxygen measured in mmHg. PaO2 determined for the difference between Intervention 1 and Intervention 2. | No PaO2 data was obtained or recorded as such. Physicians directly calculated PaO2/FiO2 data shown above in Outcome Measure 2. | Posted | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment. |
|
|
| Secondary | Dynamic Compliance (Cdyn) | Dynamic compliance is a measurement of the resistance of the lungs and airways to gas installation from the mechanical ventilator and is measured as Peak airway pressure / Plateau airway pressure - PEEP). Dynamic compliance determined for the difference between Intervention 1 and Intervention 2. | Dynamic compliance was not recorded due to the attempt of investigative personnel to limit time exposure to Coronavirus disease 19 (COVID-19) in most study participants. | Posted | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment. |
|
|
| Secondary | Change in Compliance Over the Last 20% of Inspiration (C20/Dyn) | C20 is the compliance that results when only the upper 20% of the applied pressure range is taken into account. The C20/Dyn ratio appears to effectively quantitate evidence of lung over distention during mechanical ventilation. This is a unit-less measure as both numerator and denominator are measured in cm water. C20/dyn determined for the difference between Intervention 1 and Intervention 2. | C20/Dyn was not recorded due to the attempt of investigative personnel to limit time exposure to COVID-19 in most study participants. | Posted | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at baseline and end of treatment. |
|
|
| Secondary | Ultrasound Surrogates of Lung Aeration | Lung ultrasound inflation scores are calculated by summing regional scores (0-3 points), with higher scores indicating worse condition of the lung. Scores were obtained in six regions of each lung (i.e., up and down anterior, medial, and posterior chest wall). This is a unit-less measure. Ultrasound lung surrogates of lung inflation determined for the difference between Intervention 1 and Intervention 2. | Lung ultrasound was not recorded due to the attempt of investigative personnel to limit time exposure to COVID-19 in most study participants. | Posted | Participants received Treatment 1 (either Usual Care or PEEP EIT) for approximately 6 hours after randomization and then received Treatment 2 for an additional 14-18 hours following crossover. Measurement was done at end of treatment. |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | PEEP | PEEP titration by EIT: PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP). | 0 | 16 | 0 | 16 | 0 | 16 |
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |