Trial Outcomes & Findings for Assessing Ventilator Safety in Patients on Pressure-Support Ventilation (NCT NCT05125952)
NCT ID: NCT05125952
Last Updated: 2025-10-15
Results Overview
Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Study day 1
Results posted on
2025-10-15
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Viasys Avea Ventilator
|
15
|
|
Overall Study
Philips Respironics NM3 Device
|
15
|
|
Overall Study
Servo U Ventilator
|
15
|
|
Overall Study
Vyaire SmartCath Adult Nasogastric Tube With Esophageal Balloon
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Assessing Ventilator Safety in Patients on Pressure-Support Ventilation
Baseline characteristics by cohort
| Measure |
Acute Respiratory Failure
n=15 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study day 1Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.
Outcome measures
| Measure |
Acute Respiratory Failure
n=15 Participants
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.
|
|---|---|
|
Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo)
|
12.3 centimeters of water
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: Study day 1Population: Not measured in 6 patients after Philips announced discontinuation of support for NM3.
Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.
Outcome measures
| Measure |
Acute Respiratory Failure
n=9 Participants
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.
|
|---|---|
|
Respiratory System Driving Pressure Measure by Respironics NM3 Device (DPrs-NM3)
|
8.8 centimeters of water
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Study day 1Maximum 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.
Outcome measures
| Measure |
Acute Respiratory Failure
n=15 Participants
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.
|
|---|---|
|
Airway Occlusion Test (AOC)
|
17.4 centimeters of water
Standard Deviation 10.1
|
PRIMARY outcome
Timeframe: Study day 1Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.
Outcome measures
| Measure |
Acute Respiratory Failure
n=15 Participants
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.
|
|---|---|
|
Respiratory System Driving Pressure Measured During Volume Control Breath.
|
12.3 centimeters of water
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: Study day 1Population: Not measured in 7 patients who could not have esophageal balloon placed.
Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.
Outcome measures
| Measure |
Acute Respiratory Failure
n=8 Participants
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.
|
|---|---|
|
Transpulmonary Driving Pressure Measured During Volume Control Breath.
|
9.5 centimeters of water
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Index hospitalization (up to 28 days)Population: Not measured in 3 patients who were never extubated.
Number of days receiving mechanical ventilation
Outcome measures
| Measure |
Acute Respiratory Failure
n=12 Participants
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.
|
|---|---|
|
Duration of Mechanical Ventilation
|
12.4 days
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Index hospitalization (up to 28 days)Population: Not measured for 5 patients who did not survive to ICU discharge.
Number of days admitted to intensive care unit
Outcome measures
| Measure |
Acute Respiratory Failure
n=10 Participants
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.
|
|---|---|
|
Duration of Intensive Care Unit Admission
|
17.2 days
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: Index hospitalization (up to 28 days)Population: Not measured in 8 patients who did not survive to hospital discharge.
Number of days admitted to hospital
Outcome measures
| Measure |
Acute Respiratory Failure
n=7 Participants
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.
|
|---|---|
|
Duration of Hospital Admission
|
28 days
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Index hospitalization (up to 28 days)Number of days free from mechanical ventilation
Outcome measures
| Measure |
Acute Respiratory Failure
n=15 Participants
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.
|
|---|---|
|
Ventilator Free Days
|
16 days
Interval 0.0 to 21.5
|
SECONDARY outcome
Timeframe: Index hospitalization (up to 28 days)Survival to discharge
Outcome measures
| Measure |
Acute Respiratory Failure
n=15 Participants
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.
|
|---|---|
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In-hospital Survival
|
7 Participants
|
Adverse Events
Acute Respiratory Failure
Serious events: 1 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Acute Respiratory Failure
n=15 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Agitation
|
6.7%
1/15 • Number of events 1 • 28 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place