Cardiac SurgeryNCT07189026
Prevalence and Clinical Impact of Airway Opening Pressure in Post-Cardiac Surgery Patients
A study testing Airway opening pressure in people with Cardiac Surgery and Mechanical Ventilation After Surgery, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Cardiac Surgery, Mechanical Ventilation After Surgery
- What is being tested?
- Airway opening pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult (≥18 years)
- Undergoing elective coronary artery bypass grafting (CABG) or valve surgery, or combined procedures with expected postoperative mechanical ventilation
Who cannot join
- Patient receiving invasive mechanical ventilation prior to surgery
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec
About this study
Official title: Prevalence and Clinical Impact of Airway Opening Pressure in Post-Cardiac Surgery Patients: A Prospective Observational Study
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.
- Being tested
- Airway opening pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway opening pressureDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Post operative cardiac surgery | Other | Not described Receives: Diagnostic Test: Airway opening pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of significant airway opening pressure
airway opening pressure ≥ 5 cmH₂O
Measured: up to 1 hour after intensive care admission
Secondary outcomes (13)
Airway opening pressure prevalence based on body mass index
Airway opening pressure prevalence base on Obesity status (body mass index ≥30 vs. <30 kg/m²)
Measured: up to 1 hour
Airway opening pressure prevalence based on cardiopulmonary bypass duration
Airway opening pressure prevalence based on cardiopulmonary bypass duration (minutes)
Measured: up to 1 hour
Airway opening pressure prevalence based on left ventricular dysfunction
Airway opening pressure prevalence based on left ventricular dysfunction (Ieft ventricular ejection fraction < 50 percent vs > 50 percent)
Measured: up to 1 hour
Airway opening pressure prevalence based on inotropic support
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)
Measured: up to 1 hour
Airway opening pressure prevalence based on age
Airway opening pressure prevalence base on age
Measured: up to 1 hour
Airway opening pressure prevalence based on intraoperative fluid balance
Airway opening pressure prevalence base on intraoperative fluid balance
Measured: up to 1 hour
Feasibility of airway opening pressure measurement
proportion of patients in whom the maneuver is successfully completed
Measured: up to 1 hour
Positive end expiratory pressure level
Number of times Positive end expiratory pressure is set greater than measured airway opening pressure
Measured: up to 1 hour
Extubation
Correlation between airway opening pressure and time to extubation
Measured: Day7
Patient position
Comparison of airway opening pressure values in flat versus semi-recumbent (30-degree) positions
Measured: up to 1 hour
Hemodynamic tolerance base on blood pressure drop
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)
Measured: up to 15 minutes
Hemodynamic tolerance base on pulse oxygen saturation drop
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.
Measured: up to 15 minutes
Non-interruptive airway opening pressure measurement method
The novel non-interruptive airway opening pressure measurement method will be validated
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start27 Jun 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, François Lellouche, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189026
- Sponsor's protocol ID
- 2026-4399
- Status last verified
- Nov 2026
- First submitted
- 27 Aug 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Impact of Airway Opening Pressure in Post-Cardiac Surgery Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07189026
- Acronym / sponsor ID
- 2026-4399
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post operative cardiac surgery | Other | Diagnostic Test: Airway opening pressure |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (≥18 years)
- Undergoing elective coronary artery bypass grafting (CABG) or valve surgery, or combined procedures with expected postoperative mechanical ventilation
Key exclusion criteria (1 listed)
- Patient receiving invasive mechanical ventilation prior to surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Airway opening pressureAirway 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. | Diagnostic test | Post operative cardiac surgery |
Primary outcome
Prevalence of significant airway opening pressure
Time frame: up to 1 hour after intensive care admission
airway opening pressure ≥ 5 cmH₂O
13 secondary outcomes
Airway opening pressure prevalence based on body mass index
Time frame: up to 1 hour
Airway opening pressure prevalence based on cardiopulmonary bypass duration
Time frame: up to 1 hour
Airway opening pressure prevalence based on left ventricular dysfunction
Time frame: up to 1 hour
Airway opening pressure prevalence based on inotropic support
Time frame: up to 1 hour
Airway opening pressure prevalence based on age
Time frame: up to 1 hour
Airway opening pressure prevalence based on intraoperative fluid balance
Time frame: up to 1 hour
Feasibility of airway opening pressure measurement
Time frame: up to 1 hour
Positive end expiratory pressure level
Time frame: up to 1 hour
Extubation
Time frame: Day7
Patient position
Time frame: up to 1 hour
Hemodynamic tolerance base on blood pressure drop
Time frame: up to 15 minutes
Hemodynamic tolerance base on pulse oxygen saturation drop
Time frame: up to 15 minutes
Non-interruptive airway opening pressure measurement method
Time frame: up to 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway opening pressure in people with Cardiac Surgery and Mechanical Ventilation After Surgery, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of significant airway opening pressure (time frame: up to 1 hour after intensive care admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.