VentilO Prospective Study

Not Applicable

Not yet recruiting

• Conditions: Mechanical Ventilation Complication; Respiratory Acidosis

• Registration Number: NCT06826794
• Lead Sponsor: Laval University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-28
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Study Start: 2025-05
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory acidosis	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 Outcome Measures

Name	Time	Method
Acid-base disorders on arrival in intensive care	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)

Trial Locations

Locations (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval; 🇨🇦 Quebec, Canada