Recruiting

VentilO vs. Clinician

Sponsor:

Laval University

Code:

NCT06826794

Conditions

Mechanical Ventilation Complication

Respiratory Acidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinicians

VenitlO

Study Details

Brief 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.

Conditions

Mechanical Ventilation Complication

Respiratory Acidosis

Study ID

NCT06826794

Start date

Apr 24, 2025

Status verified date

Aug, 2025

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

  • 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

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Clinicians

Clinicians include respiratory therapists, physcians, medical students

active comparator: VentilO

VentilO, smartphone application (or web plateform)

Interventions

Clinicians

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

VenitlO

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

Primary outcome measure

  • Respiratory acidosis [ Time Frame: 20 minutes after initiation of mechanical ventilation ]

Central Contacts and Locations

Central contacts

Francois Lellouche Principal investigator, MD, PhD

1-418-656-8711francois.lellouche@criucpq.ulaval.ca

Locations

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

Recruiting

Québec, Quebec, Canada, G1V4G5

Contacts

Francois Lellouche

418-656-8711francois.lellouche@criucpq.ulaval.ca

Principal Investigator:

Francois Lellouche

More Information

Sponsor

Laval University

Last update posted

Sep 4, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2025-09-04.