N/A
N=16
Assessing Ventilator Safety in Patients on Pressure-Support Ventilation
Acute Respiratory Failure · Mechanical Ventilation Complication · Ventilator-Induced Lung Injury
Bottom Line
View on ClinicalTrials.gov: NCT05125952 ↗Enrolled (actual)
16
Serious AEs
6.7%
Results posted
Oct 2025
Primary outcome: Primary: Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo) — 12.3 centimeters of water
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Viasys Avea Ventilator (Device); Philips Respironics NM3 device (Device); Servo U ventilator (Device); Vyaire SmartCath adult nasogastric tube with Esophageal balloon (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo) |
12.3 | — |
| PRIMARY Respiratory System Driving Pressure Measure by Respironics NM3 Device (DPrs-NM3) |
8.8 | — |
| PRIMARY Airway Occlusion Test (AOC) |
17.4 | — |
| PRIMARY Respiratory System Driving Pressure Measured During Volume Control Breath. |
12.3 | — |
| PRIMARY Transpulmonary Driving Pressure Measured During Volume Control Breath. |
9.5 | — |
| SECONDARY Duration of Mechanical Ventilation |
12.4 | — |
| SECONDARY Duration of Intensive Care Unit Admission |
17.2 | — |
| SECONDARY Duration of Hospital Admission |
28 | — |
| SECONDARY Ventilator Free Days |
16 | — |
| SECONDARY In-hospital Survival |
7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Adult patients age ≥18 years with acute respiratory failure receiving invasive mechanical ventilation
- Managed in pressure-support mode of ventilation
Exclusion Criteria
- Actively undergoing a spontaneously awakening trial or SAT
- Patient or surrogate is unable to provide informed consent
- Currently pregnant
- Currently incarcerated
- Acute exacerbation of an obstructive lung disease
- Known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe
- Esophageal, gastric or duodenal surgical procedures within the last 6 months
Data sourced from ClinicalTrials.gov (NCT05125952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.