Assessing Ventilator Safety in Patients on Pressure-Support Ventilation

NCT05125952 | Completed Results FDA Device

• 1 other identifier: Pro00106860
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Failure; Mechanical Ventilation Complication; Ventilator-Induced Lung Injury

Keywords

Self-induced lung injury; Pressure-support ventilation

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (5)

• Duration of Mechanical Ventilation

  Index hospitalization (up to 28 days)

• Duration of Intensive Care Unit Admission

  Index hospitalization (up to 28 days)

• Duration of Hospital Admission

  Index hospitalization (up to 28 days)

• Ventilator Free Days

  Index hospitalization (up to 28 days)

• In-hospital Survival

  Index hospitalization (up to 28 days)

Study Arms (1)

Acute Respiratory Failure

EXPERIMENTAL

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

Interventions

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.

Acute Respiratory Failure

Philips Respironics NM3 device DEVICE

Measuring static airway driving pressure during pressure support breath

Acute Respiratory Failure

Servo U ventilator DEVICE

Measuring static airway driving pressure and p0.1 during pressure support breath.

Acute Respiratory Failure

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.

Acute Respiratory Failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients age ≥18 years with acute respiratory failure receiving invasive mechanical ventilation
• Managed in pressure-support mode of ventilation

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Related Publications (6)

• 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.

  PMID: 27842744 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.

  PMID: 24283226 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.

  PMID: 33381233 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.

  PMID: 30871304 BACKGROUND

• Hess DR. Ventilator waveforms and the physiology of pressure support ventilation. Respir Care. 2005 Feb;50(2):166-86; discussion 183-6.

  PMID: 15691390 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.

  PMID: 27334266 BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Elias Pratt
• Organization: Duke University School of Medicine

elias.pratt@duke.edu

919-684-8111

Study Officials

• Neil R MacIntyre, MD

  Professor of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: February 8, 2022
• Primary Completion: November 21, 2023
• Study Completion: December 21, 2023
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)