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RecruitingNCT06826794VentilOUpdated Sep 4, 2025

VentilO Prospective Study

An interventional study of Clinicians and VenitlO in Mechanical Ventilation Complication and Respiratory Acidosis, sponsored by Laval University. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Laval University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a randomized, open-label study comparing intial settings made by clinicians with settings recommandation made by the VentilO application immediately after intensive care unit admission.The study will allow direct comparison of the frequency of acidosis when patients are ventilated using the parameters of the VentilO application versus parameters chosen by the clinician. The variables determined by the clinician or VentilO will be respiratory rate, tidal volume and resulting minute ventilation.

02

Conditions studied

  • Mechanical Ventilation Complication
  • Respiratory Acidosis
03

In context

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults (> 18 years old)
  • Intubated patients admitted to intensive care immediately post-operatively after cardiac surgery (all cardiac surgery combined)
  • Ventilation in controlled mode (Assist Control or SIMV)

Exclusion criteria

Exclusion Criteria:

  • Absence of anthropometric data (height and weight) of patients available in the patient file
  • Respiratory cycles mainly spontaneous on arrival
  • Patient extubated on arrival in intensive care
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Other
    Clinicians

    Clinicians include respiratory therapists, physcians, medical students

    Other: Clinicians

  • Active comparator
    VentilO

    VentilO, smartphone application (or web plateform)

    Device: VenitlO

Interventions

  • OtherClinicians

    Clinicians will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit.

  • DeviceVenitlO

    VentilO application (or web platerform) will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit.

06

What researchers measure

Primary outcomes

  1. Respiratory acidosis

    The frequency of respiratory acidosis on arterial gas after 20 minutes of mechanical ventilation (pH \< 7.35 and PaCO2 \> 45mmHg)

    Time frame: 20 minutes after initiation of mechanical ventilation

Secondary outcomes

  1. Acid-base disorders on arrival in intensive care

    The frequency and severity of acid-base disorders on arrival in intensive care (pH\<7.35 or pH \> 7.45)

    Time frame: 5 minutes after initiation of mechanical ventilation

Other outcomes

  1. Number of participants with hemodynamic shock - hypotension

    Requiring \>1L of volume repletion and/or use of amines at \>0.05 mcg/kg/min or norepinephrine equivalent

    Time frame: Up to extubation

  2. Number of participants with a barotrauma

    Presence of pneumothorax

    Time frame: Up to extubation

  3. Mortality

    Intensive care unit mortality

    Time frame: Up to intensive care unit discharge

  4. Intensive care unit lenght of stay

    Intensive care unit lenght of stay

    Time frame: Up to 28 days - intensive care unit length of stay - intensive care admission to intensive care discharge

  5. Number of participants with an acute kidney injury

    Acute kidney injury define by \> 27 mmol for 48 hours or 1.5 x basline value (pre surgery)

    Time frame: Up to 28 days - intensive care unit length of stay - intensive care admission to intensive care discharge

07

Study locations

1 of 1 sites recruiting
  • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
    Québec, Quebec G1V4G5, Canada
    Recruiting
08

References and documents

Publications

  • Roch R, Bouchard PA, Couture E, Lellouche F. Patient-Centered Ventilator Settings to Reduce Respiratory Acidosis After Cardiac Surgery. Respir Care. 2026 Apr;71(4):366-374. doi: 10.1177/19433654251412340. Epub 2026 Feb 19. PubMed 41711585 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06826794
Lead sponsor
Laval University
Responsible party
François Lellouche (Principal investigator, Laval University) — Principal investigator
First posted
Feb 14, 2025
Start date
Apr 24, 2025
Primary completion
Dec 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 4, 2025

Study contacts

Francois Lellouche Principal investigator, MD, PhD
Contact
francois.lellouche@criucpq.ulaval.ca
1-418-656-8711 ext. 3572

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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