VentilO Prospective Study (VentilO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation Complication; Respiratory Acidosis
• Intervention / Treatment: Other: Clinicians; Device: VenitlO

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francois Lellouche Principal investigator, MD, PhD; Phone Number: 3572 1-418-656-8711; Email: francois.lellouche@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V4G5
      • Recruiting
      • Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
      • Contact: Francois Lellouche; Phone Number: 418-656-8711; Email: francois.lellouche@criucpq.ulaval.ca
      • Principal Investigator: Francois Lellouche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Clinicians; Clinicians include respiratory therapists, physcians, medical students	Other: Clinicians; Clinicians will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit.
Active Comparator: VentilO; VentilO, smartphone application (or web plateform)	Device: VenitlO; VentilO application (or web platerform) will determine respiratory parameters for mechanical ventilation upon arrival in the intensive care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory acidosis	The frequency of respiratory acidosis on arterial gas after 20 minutes of mechanical ventilation (pH < 7.35 and PaCO2 > 45mmHg)	20 minutes after initiation of mechanical ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	5 minutes after initiation of mechanical ventilation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to extubation
Number of participants with a barotrauma	Presence of pneumothorax	Up to extubation
Mortality	Intensive care unit mortality	Up to intensive care unit discharge
Intensive care unit lenght of stay	Intensive care unit lenght of stay	Up to 28 days - intensive care unit length of stay - intensive care admission to intensive care discharge
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)	Up to 28 days - intensive care unit length of stay - intensive care admission to intensive care discharge

Collaborators and Investigators

• Sponsor: Laval University

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Acid-Base Imbalance; Acidosis; Nutritional and Metabolic Diseases; Acidosis, Respiratory; Health Care Facilities Workforce and Services; Health Personnel; Nurse Specialists; Nurses; Nurse Clinicians
• Other Study ID Numbers: 2025-4300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No