NCT07189026

Brief Summary

Airway opening pressure is a key parameter in assessing respiratory mechanics. Current practice primarily relies on indirect assessments of lung mechanics, but growing evidence suggests that direct airway opening pressure measurement could enhance individualized ventilatory strategies. Significant airway opening pressure suggests incomplete alveolar recruitment at end-expiration, which may contribute to ventilation-perfusion mismatch, increased respiratory effort, and postoperative pulmonary complications such as atelectasis and impaired gas exchange. Determining the prevalence and clinical relevance of significant airway opening pressure in post-cardiac surgery patients could contribute to more personalized respiratory strategies and improve postoperative care.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Jun 2025Jun 2027

Study Start

First participant enrolled

June 27, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

August 27, 2025

Last Update Submit

September 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of significant airway opening pressure

    airway opening pressure ≥ 5 cmH₂O

    up to 1 hour after intensive care admission

Secondary Outcomes (13)

  • Airway opening pressure prevalence based on body mass index

    up to 1 hour

  • Airway opening pressure prevalence based on cardiopulmonary bypass duration

    up to 1 hour

  • Airway opening pressure prevalence based on left ventricular dysfunction

    up to 1 hour

  • Airway opening pressure prevalence based on inotropic support

    up to 1 hour

  • Airway opening pressure prevalence based on age

    up to 1 hour

  • +8 more secondary outcomes

Study Arms (1)

Post operative cardiac surgery

OTHER
Diagnostic Test: Airway opening pressure

Interventions

Airway opening pressure will be measured within one hour of intensive care unit admission (using a standardized low-flow insufflation maneuver flow 5-6 LPM). The inflection point on the pressure-time or pressure-volume waveform- depending on ventilator model-will define the airway opening pressure.

Post operative cardiac surgery

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (≥18 years)
  • Undergoing elective coronary artery bypass grafting (CABG) or valve surgery, or combined procedures with expected postoperative mechanical ventilation

You may not qualify if:

  • \- Patient receiving invasive mechanical ventilation prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, Quebec, Canada

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 23, 2025

Study Start

June 27, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations