Potential Impact of the Use of the Application VentilO After Cardiac Surgery

Active, not recruiting

• Conditions: Mechanical Ventilation Complication
• Interventions: Other: VentilO application

• Registration Number: NCT05886413
• Lead Sponsor: Laval University

Brief Summary

Mechanical ventilation is a vital support associated with the treatment of patients with acute respiratory failure and in other indications such as surgery under general anesthesia, coma or shock. Optimization of settings during mechanical ventilation and implementation of protective ventilation help to avoid ventilation-induced injury, ensure adequate oxygenation and maintain adequate carbon dioxide concentration to avoid respiratory acidosis or alkalosis.

Similarly, there is also no clear recommendation, to our knowledge, for the initial setting of the respiratory rate. Therefore, initial settings are not always adequate and in the literature the frequency of respiratory acidosis is very high, reaching about half of the patients receiving mechanical ventilation.

VentilO, is an application that is available on smart phones. This educational application provides clinicians with initial settings and optimization of these settings based on gender, height, weight, body temperature and patient type. The algorithm used is based on published data regarding ventilatory requirements in different populations and the anatomical and instrumental dead space of patients.

The purpose of our study is to:

Assess whether ventilatory settings after intensive care unit admission after cardiac surgery are appropriate to compare the ventilatory adjustments made by clinicians with those proposed by the VentilO application.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-02
• Study Start: 2023-08-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adults (> or = 18 years old)
• Intubated patients admitted to the ICU immediately postoperative from cardiac surgery
• Obtained a postoperative arterial gas within 1 hour of arrival in the ICU

Exclusion Criteria

• Lack of patient anthropometric data (height and weight) available in the patient record

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intubated patient admitted in intensive care unit at the IUCPQ-UL after cardiac surgery	VentilO application	-

Primary Outcome Measures

Name	Time	Method
acid-base abnormalities on arterial blood gases	On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission	Evaluate the frequency of acid-base abnormalities, either acidosis or alkalosis, of respiratory or mixed origin on the first arterial gases after intubation.; Respiratory acidosis is defined as a pH \< 7.35 with a PaCO2 \> 45 mmHg, and respiratory alkalosis as a pH \> 7.45 with a PaCO2 \< 35 mmHg)

Secondary Outcome Measures

Name	Time	Method
hemodynamic instabilities	Between Hour0 to Hour1 after intensive care unit admission	Number of arterial hypotension requiring vascular filling \> 1000 ml and/or use of vasopressors or inotropes such as levophed or adrenaline at \> 0.05 mcg/kg/min)
Acute renal failure	up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured	rate of acute renal failure during ICU length of stay. Renal failure will be defined according to the usual criteria, i.e., an increase of \>27 mmol/L creatinine in 48 hours or 1.5x over the preoperative baseline
Severity of unbalance of arterial blood gases result	On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission	For acid-base abnormalities, they will be evaluated according to their level of severity: the frequency of moderate (pH between 7.30 and 7.34) and severe (pH \< 7.30) acidoses, and the frequency of moderate (pH between 7.46 and 7.50) and severe (pH \> 7.50) alkaloses.; The frequency of moderate (PaCO2 between 46 and 50 mmHg) and severe (PaCO2 \> 50 mmHg) hypercapnia, and the frequency of moderate (PaCO2 between 31 and 35 mmHg) and severe (PaCO2 \< 31 mmHg) hypocapnia.
Mechanical Ventilation duration	up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured	Time spent with invasive mechanical ventilation during ICU length of stay
Hospital length of stay	up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured	Hospital length of stay - ICU admission through hospital discharge
Occurence of optimal arterial blood gases result	On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission	An optimal arterial blood gases as defined by a pH between 7.35 and 7.45 with a PaCO2 between 36 and 45 mmHg
ICU length of stay	up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured	ICU length of stay - ICU admission through ICU discharge
ICU mortality	up to 90 days. ICU admission through until death if occured	Occurence of death during ICU stay

Trial Locations

Locations (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec; 🇨🇦 Quebec, Canada