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Completed

NCT Number: NCT05125952

Assessing Ventilator Safety in Patients on Pressure-Support Ventilation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Philips Respironics NM3 device

Device

Measuring static airway driving pressure during pressure support breath

Servo U ventilator

Device

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

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.

Primary outcomes

  1. Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo)

    Time frame: Study day 1

    Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.

  2. Respiratory System Driving Pressure Measure by Respironics NM3 Device (DPrs-NM3)

    Time frame: Study day 1

    Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.

  3. Airway Occlusion Test (AOC)

    Time frame: Study day 1

    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.

  4. Respiratory System Driving Pressure Measured During Volume Control Breath.

    Time frame: Study day 1

    Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.

  5. Transpulmonary Driving Pressure Measured During Volume Control Breath.

    Time frame: Study day 1

    Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.

Secondary outcomes

  1. Duration of Mechanical Ventilation

    Time frame: Index hospitalization (up to 28 days)

    Number of days receiving mechanical ventilation

  2. Duration of Intensive Care Unit Admission

    Time frame: Index hospitalization (up to 28 days)

    Number of days admitted to intensive care unit

  3. Duration of Hospital Admission

    Time frame: Index hospitalization (up to 28 days)

    Number of days admitted to hospital

  4. Ventilator Free Days

    Time frame: Index hospitalization (up to 28 days)

    Number of days free from mechanical ventilation

  5. In-hospital Survival

    Time frame: Index hospitalization (up to 28 days)

    Survival to discharge

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: ASOP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2021
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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