Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06826794

VentilO Prospective Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Mechanical Ventilation Complication Acid-Base Imbalance Acidosis Acidosis, Respiratory Metabolic Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Acidosis Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year 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, G1V4G5, Canada

Location status: Recruiting

Location contact

Francois Lellouche

CONTACT

[email protected]

418-656-8711

Francois Lellouche

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Clinicians

Other

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

VenitlO

Device

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

Primary outcomes

  1. Respiratory acidosis

    Time frame: 20 minutes after initiation of mechanical ventilation

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

Secondary outcomes

  1. Acid-base disorders on arrival in intensive care

    Time frame: 5 minutes after initiation of mechanical ventilation

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

Other outcomes

  1. Number of participants with hemodynamic shock - hypotension

    Time frame: Up to extubation

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

  2. Number of participants with a barotrauma

    Time frame: Up to extubation

    Presence of pneumothorax

  3. Mortality

    Time frame: Up to intensive care unit discharge

    Intensive care unit mortality

  4. 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

    Intensive care unit lenght of stay

  5. Number of participants with an acute kidney injury

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Francois Lellouche Principal investigator, MD, PhD

CONTACT

[email protected]

1-418-656-8711 ext. 3572

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

Frequency of Respiratory Acidosis in the Intensive Care Unit After Postoperative Cardiac Surgery. Impact of Using VentilO Application

Acronym: VentilO

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 14, 2025
Registry last updated
Sep 4, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.