VentilO Prospective Study

NCT06826794 | Recruiting

• 1 other identifier: 2025-4300
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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)

  20 minutes after initiation of mechanical ventilation

Secondary Outcomes (1)

• Acid-base disorders on arrival in intensive care

  5 minutes after initiation of mechanical ventilation

Other Outcomes (5)

• Number of participants with hemodynamic shock - hypotension

  Up to extubation

• Number of participants with a barotrauma

  Up to extubation

• Mortality

  Up to intensive care unit discharge

Study Arms (2)

Clinicians

OTHER

Clinicians include respiratory therapists, physcians, medical students

Other: Clinicians

VentilO

ACTIVE COMPARATOR

VentilO, smartphone application (or web plateform)

Device: VenitlO

Interventions

Clinicians OTHER

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

Clinicians

VenitlO DEVICE

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

VentilO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

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

Québec, Quebec, G1V4G5, Canada

RECRUITING

MeSH Terms

Conditions

Acidosis, Respiratory

Interventions

Nurse Clinicians

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nurse Specialists; Nurses; Health Personnel; Health Care Facilities Workforce and Services

Central Study Contacts

Francois Lellouche Principal investigator, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 14, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)