An interventional study of Viasys Avea Ventilator and Philips Respironics NM3 device in Acute Respiratory Failure, Mechanical Ventilation Complication and Ventilator-Induced Lung Injury, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-15.
Sponsored by Duke University · Not applicable, Interventional, and Diagnostic
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.
97 studies on the registry are indexed under Ventilator-Induced Lung Injury; 35 are open to participants now.
This study's enrollment of 16 is below the median of 37 across 58 interventional studies indexed under Ventilator-Induced Lung Injury.
Browse Ventilator-Induced Lung Injury studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with acute respiratory failure managed with pressure-support ventilation.
Device: Viasys Avea Ventilator · Device: Philips Respironics NM3 device · Device: Servo U ventilator · Device: Vyaire SmartCath adult nasogastric tube with Esophageal balloon
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.
Measuring static airway driving pressure during pressure support breath
Measuring static airway driving pressure and p0.1 during pressure support breath.
Measuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Study day 1
Duration of Mechanical Ventilation
Number of days receiving mechanical ventilation
Time frame: Index hospitalization (up to 28 days)
Duration of Intensive Care Unit Admission
Number of days admitted to intensive care unit
Time frame: Index hospitalization (up to 28 days)
Duration of Hospital Admission
Number of days admitted to hospital
Time frame: Index hospitalization (up to 28 days)
Ventilator Free Days
Number of days free from mechanical ventilation
Time frame: Index hospitalization (up to 28 days)
In-hospital Survival
Survival to discharge
Time frame: Index hospitalization (up to 28 days)
| Milestone | Acute Respiratory Failure |
|---|---|
| Started | 16 |
| Viasys avea ventilator | 15 |
| Philips respironics nm3 device | 15 |
| Servo u ventilator | 15 |
| Vyaire smartcath adult nasogastric tube with esophageal balloon | 15 |
| Completed | 15 |
| Not completed | 1 |
| Withdrew: Physician decision | 1 |
Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.
| centimeters of water | Acute Respiratory Failure |
|---|---|
| Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo) | 12.3 ± 2.9 |
Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.
| centimeters of water | Acute Respiratory Failure |
|---|---|
| Respiratory System Driving Pressure Measure by Respironics NM3 Device (DPrs-NM3) | 8.8 ± 3.2 |
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.
| centimeters of water | Acute Respiratory Failure - Esophageal Balloon |
|---|---|
| Airway Occlusion Test (AOC) | 17.4 ± 10.1 |
Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.
| centimeters of water | Acute Respiratory Failure |
|---|---|
| Respiratory System Driving Pressure Measured During Volume Control Breath. | 12.3 ± 3.4 |
Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.
| centimeters of water | Acute Respiratory Failure |
|---|---|
| Transpulmonary Driving Pressure Measured During Volume Control Breath. | 9.5 ± 3.6 |
Number of days receiving mechanical ventilation
| days | Acute Respiratory Failure |
|---|---|
| Duration of Mechanical Ventilation | 12.4 ± 9.1 |
Number of days admitted to intensive care unit
| days | Acute Respiratory Failure |
|---|---|
| Duration of Intensive Care Unit Admission | 17.2 ± 6.9 |
Number of days admitted to hospital
| days | Acute Respiratory Failure |
|---|---|
| Duration of Hospital Admission | 28 ± 0.8 |
Number of days free from mechanical ventilation
| days | Acute Respiratory Failure |
|---|---|
| Ventilator Free Days | 16 (0 to 21.5) |
Survival to discharge
| Participants | Acute Respiratory Failure |
|---|---|
| In-hospital Survival | 7 |
Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acute Respiratory Failure | 8/15 (53.3%) | 1/15 (6.7%) | 0/15 (0%) |
| Event | Acute Respiratory Failure |
|---|---|
| AgitationNervous system disorders | 1/15 |
Participants who completed the study.
| Age, Categorical(Participants) | Acute Respiratory Failure |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 7 |
| Age, Continuous(years) | Acute Respiratory Failure |
|---|---|
| Median | 63 (37 to 71) |
| Sex: Female, Male(Participants) | Acute Respiratory Failure |
|---|---|
| Female | 6 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Acute Respiratory Failure |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Acute Respiratory Failure |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 10 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(Participants) | Acute Respiratory Failure |
|---|---|
| United States | 15 |
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Ventilator-Induced Lung Injury→
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