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ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation. We will describe the relationship between three different assessment methods for risk of self-induced lung injury and compare them to a gold standard measurement.
Ventilator-induced lung injury (VILI) is known to cause significant morbidity and mortality in patients with acute respiratory failure. Most studies on VILI have involved the effects of inappropriate (often excessive) mechanical ventilator settings. More recently, it has been noted that similar lung damage can be caused by large, patient generated, uncontrolled tidal volumes and driving pressures, which has been termed "self-induced lung injury," or SILI.
Pressure-support ventilation (PSV) is a common mechanical ventilation mode often used in patients with active inspiratory efforts to help reduce patient inspiratory work and improve comfort. PSV effectively allows spontaneously breathing patients to determine their breath flow-rate and breath duration, eliminating flow and cycle dyssynchrony. However, pressure support ventilation does not allow for physicians to control tidal volume or driving pressure. The risk of SILI may thus be increased with PSV.
Several different methods have been proposed to address these challenges. However, to date none of these methods have been compared to assess for concordance in their ability to indicate an increased risk of self-induced lung injury. ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Respiratory Failure | Experimental | Patients with acute respiratory failure managed with pressure-support ventilation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viasys Avea Ventilator | Device | Measuring dynamic airway driving pressure and static airway driving pressure during pressure support breath, and static airway driving pressure during a volume control breath. Measuring airway occlusion pressure during pressure support breath. |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo) | Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation. | Study day 1 |
| Respiratory System Driving Pressure Measure by Respironics NM3 Device (DPrs-NM3) | Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation. | Study day 1 |
| Airway Occlusion Test (AOC) | Maximum negative airway pressure in centimeters of water during an airway occlusion maneuver. The Vyaire SmartCath adult nasogastric tube with esophageal balloon was used to measure esophogeal pressure change during airway occlusion maneuver. | Study day 1 |
| Respiratory System Driving Pressure Measured During Volume Control Breath. | Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control. | Study day 1 |
| Transpulmonary Driving Pressure Measured During Volume Control Breath. | Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control. | Study day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Mechanical Ventilation | Number of days receiving mechanical ventilation | Index hospitalization (up to 28 days) |
| Duration of Intensive Care Unit Admission | Number of days admitted to intensive care unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil R MacIntyre, MD | Professor of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27842744 | Background | Beitler JR, Malhotra A, Thompson BT. Ventilator-induced Lung Injury. Clin Chest Med. 2016 Dec;37(4):633-646. doi: 10.1016/j.ccm.2016.07.004. Epub 2016 Oct 14. | |
| 24283226 | Background | Slutsky AS, Ranieri VM. Ventilator-induced lung injury. N Engl J Med. 2013 Nov 28;369(22):2126-36. doi: 10.1056/NEJMra1208707. No abstract available. |
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Participants were randomized to different sequences of receiving the 4 different measurement methods: Viasys Avea Ventilator, Philips Respironics NM3 device, Servo U ventilator, and Vyaire SmartCath adult nasogastric tube with Esophageal balloon.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acute Respiratory Failure | Patients with acute respiratory failure managed with pressure-support ventilation. Viasys Avea Ventilator: Measuring dynamic airway driving pressure and static airway driving pressure during pressure support breath, and static airway driving pressure during a volume control breath. Measuring airway occlusion pressure during pressure support breath. Philips Respironics NM3 device: Measuring static airway driving pressure during pressure support breath Servo U ventilator: Measuring static airway driving pressure and p0.1 during pressure support breath. Vyaire SmartCath adult nasogastric tube with Esophageal balloon: Measuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 26, 2022 | Oct 29, 2024 |
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| Philips Respironics NM3 device | Device | Measuring static airway driving pressure during pressure support breath |
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| Servo U ventilator | Device | Measuring static airway driving pressure and p0.1 during pressure support breath. |
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| Vyaire SmartCath adult nasogastric tube with Esophageal balloon | Device | Measuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver. |
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| Index hospitalization (up to 28 days) |
| Duration of Hospital Admission | Number of days admitted to hospital | Index hospitalization (up to 28 days) |
| Ventilator Free Days | Number of days free from mechanical ventilation | Index hospitalization (up to 28 days) |
| In-hospital Survival | Survival to discharge | Index hospitalization (up to 28 days) |
| 33381233 | Background | Sottile PD, Albers D, Smith BJ, Moss MM. Ventilator dyssynchrony - Detection, pathophysiology, and clinical relevance: A Narrative review. Ann Thorac Med. 2020 Oct-Dec;15(4):190-198. doi: 10.4103/atm.ATM_63_20. Epub 2020 Oct 10. |
| 30871304 | Background | Grieco DL, Menga LS, Eleuteri D, Antonelli M. Patient self-inflicted lung injury: implications for acute hypoxemic respiratory failure and ARDS patients on non-invasive support. Minerva Anestesiol. 2019 Sep;85(9):1014-1023. doi: 10.23736/S0375-9393.19.13418-9. Epub 2019 Mar 12. |
| 15691390 | Background | Hess DR. Ventilator waveforms and the physiology of pressure support ventilation. Respir Care. 2005 Feb;50(2):166-86; discussion 183-6. |
| 27334266 | Background | Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22. |
| Viasys Avea Ventilator |
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| Philips Respironics NM3 Device |
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| Servo U Ventilator |
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| Vyaire SmartCath Adult Nasogastric Tube With Esophageal Balloon |
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| COMPLETED |
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| NOT COMPLETED |
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Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acute Respiratory Failure | Patients with acute respiratory failure managed with pressure-support ventilation. Viasys Avea Ventilator: Measuring dynamic airway driving pressure and static airway driving pressure during pressure support breath, and static airway driving pressure during a volume control breath. Measuring airway occlusion pressure during pressure support breath. Philips Respironics NM3 device: Measuring static airway driving pressure during pressure support breath Servo U ventilator: Measuring static airway driving pressure and p0.1 during pressure support breath. Vyaire SmartCath adult nasogastric tube with Esophageal balloon: Measuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo) | Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation. | Posted | Mean | Standard Deviation | centimeters of water | Study day 1 |
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| Primary | Respiratory System Driving Pressure Measure by Respironics NM3 Device (DPrs-NM3) | Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation. | Not measured in 6 patients after Philips announced discontinuation of support for NM3. | Posted | Mean | Standard Deviation | centimeters of water | Study day 1 |
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| Primary | Airway Occlusion Test (AOC) | Maximum negative airway pressure in centimeters of water during an airway occlusion maneuver. The Vyaire SmartCath adult nasogastric tube with esophageal balloon was used to measure esophogeal pressure change during airway occlusion maneuver. | Posted | Mean | Standard Deviation | centimeters of water | Study day 1 |
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| Primary | Respiratory System Driving Pressure Measured During Volume Control Breath. | Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control. | Posted | Mean | Standard Deviation | centimeters of water | Study day 1 |
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| Primary | Transpulmonary Driving Pressure Measured During Volume Control Breath. | Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control. | Not measured in 7 patients who could not have esophageal balloon placed. | Posted | Mean | Standard Deviation | centimeters of water | Study day 1 |
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| Secondary | Duration of Mechanical Ventilation | Number of days receiving mechanical ventilation | Not measured in 3 patients who were never extubated. | Posted | Mean | Standard Deviation | days | Index hospitalization (up to 28 days) |
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| Secondary | Duration of Intensive Care Unit Admission | Number of days admitted to intensive care unit | Not measured for 5 patients who did not survive to ICU discharge. | Posted | Mean | Standard Deviation | days | Index hospitalization (up to 28 days) |
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| Secondary | Duration of Hospital Admission | Number of days admitted to hospital | Not measured in 8 patients who did not survive to hospital discharge. | Posted | Mean | Standard Deviation | days | Index hospitalization (up to 28 days) |
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| Secondary | Ventilator Free Days | Number of days free from mechanical ventilation | Posted | Median | Inter-Quartile Range | days | Index hospitalization (up to 28 days) |
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| Secondary | In-hospital Survival | Survival to discharge | Posted | Count of Participants | Participants | Index hospitalization (up to 28 days) |
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28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acute Respiratory Failure | Patients with acute respiratory failure managed with pressure-support ventilation. Viasys Avea Ventilator: Measuring dynamic airway driving pressure and static airway driving pressure during pressure support breath, and static airway driving pressure during a volume control breath. Measuring airway occlusion pressure during pressure support breath. Philips Respironics NM3 device: Measuring static airway driving pressure during pressure support breath Servo U ventilator: Measuring static airway driving pressure and p0.1 during pressure support breath. Vyaire SmartCath adult nasogastric tube with Esophageal balloon: Measuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver. | 8 | 15 | 1 | 15 | 0 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Nervous system disorders | Non-systematic Assessment | One patient became agitated due to study measurements that required an increase in the dose of sedative medication that they were using. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elias Pratt | Duke University School of Medicine | 919-684-8111 | elias.pratt@duke.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2024 | Oct 29, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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