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NCT Number: NCT07189026

Prevalence and Clinical Impact of Airway Opening Pressure in Post-Cardiac Surgery Patients

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.

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Key information

Conditions

Cardiac Surgery Mechanical Ventilation After Surgery

Age range

18 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Québec, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Patient receiving invasive mechanical ventilation prior to surgery

Treatment and study plan

Airway opening pressure

Diagnostic Test

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.

Primary outcomes

  1. Prevalence of significant airway opening pressure

    Time frame: up to 1 hour after intensive care admission

    airway opening pressure ≥ 5 cmH₂O

Secondary outcomes

  1. Airway opening pressure prevalence based on body mass index

    Time frame: up to 1 hour

    Airway opening pressure prevalence base on Obesity status (body mass index ≥30 vs. <30 kg/m²)

  2. Airway opening pressure prevalence based on cardiopulmonary bypass duration

    Time frame: up to 1 hour

    Airway opening pressure prevalence based on cardiopulmonary bypass duration (minutes)

  3. Airway opening pressure prevalence based on left ventricular dysfunction

    Time frame: up to 1 hour

    Airway opening pressure prevalence based on left ventricular dysfunction (Ieft ventricular ejection fraction < 50 percent vs > 50 percent)

  4. Airway opening pressure prevalence based on inotropic support

    Time frame: up to 1 hour

    Airway opening pressure prevalence based on use of amines (< 0.1 mcg/kg/min or norepinephrine equivalent vs > 0.1 mcg/kg/min or norepinephrine equivalent)

  5. Airway opening pressure prevalence based on age

    Time frame: up to 1 hour

    Airway opening pressure prevalence base on age

  6. Airway opening pressure prevalence based on intraoperative fluid balance

    Time frame: up to 1 hour

    Airway opening pressure prevalence base on intraoperative fluid balance

  7. Feasibility of airway opening pressure measurement

    Time frame: up to 1 hour

    proportion of patients in whom the maneuver is successfully completed

  8. Positive end expiratory pressure level

    Time frame: up to 1 hour

    Number of times Positive end expiratory pressure is set greater than measured airway opening pressure

  9. Extubation

    Time frame: Day7

    Correlation between airway opening pressure and time to extubation

  10. Patient position

    Time frame: up to 1 hour

    Comparison of airway opening pressure values in flat versus semi-recumbent (30-degree) positions

  11. Hemodynamic tolerance base on blood pressure drop

    Time frame: up to 15 minutes

    Evaluation of hemodynamic tolerance based on arterial pressure during positive end-expiratory pressure adjustment (if inotropic agents are required, an increase of more than 0.05 mcg/kg/min in norepinephrine equivalent is considered significant)

  12. Hemodynamic tolerance base on pulse oxygen saturation drop

    Time frame: up to 15 minutes

    Evaluation of hemodynamic tolerance based on pulse oxygen saturation. A decrease in pulse oxygen saturation of 5 percent from baseline or more is considered significant.

  13. Non-interruptive airway opening pressure measurement method

    Time frame: up to 1 hour

    The novel non-interruptive airway opening pressure measurement method will be validated

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Prevalence and Clinical Impact of Airway Opening Pressure in Post-Cardiac Surgery Patients: A Prospective Observational Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 23, 2025
Registry last updated
Sep 23, 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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