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

Mechanical Ventilation Complication Clinical Trial

Official title:

Frequency of Respiratory Acidosis and Alkalosis in Intensive Care Department of the IUCPQ-UL After Cardiac Surgery. Potential Impact of the Use of the Application VentilO

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05886413
• Other study ID #: 2023-4030
• Status: Active, not recruiting
• Start date: August 24, 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Other:
• VentilO application
This educational application provides clinicians with combinations of tidal volume and respiratory rate based on gender, height, weight, body temperature and patient type. The algorithm used is based on published data regarding ventilatory requirements in different populations (i.e. from intubated patients for scheduled surgery to the most severe ICU patients) and anatomical and instrumental dead space. The objective of this application is to help implement personalized protective ventilation in intubated patients according to their characteristics. After patient data entry in the VentilO application, the investigators will compare the recommended settings (for mechanical ventilation) vs the real clinician settings done by clinician after patient admission in ICU after cardiac surgery. The investigators will evaluated the potential effect of the VentilO recommendation on the first arterial (or capillary) blood gases compared to the real settings.

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acid-base abnormalities on arterial blood gases	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)	On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission
Secondary	Occurence of optimal arterial blood gases result	An optimal arterial blood gases as defined by a pH between 7.35 and 7.45 with a PaCO2 between 36 and 45 mmHg	On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission
Secondary	Severity of unbalance of arterial blood gases result	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.	On the first result available of arterial blood gases after intensive care unit admission; 1 hour maximum after intensive care admission
Secondary	hemodynamic instabilities	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)	Between Hour0 to Hour1 after intensive care unit admission
Secondary	ICU length of stay	ICU length of stay - ICU admission through ICU discharge	up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
Secondary	Mechanical Ventilation duration	Time spent with invasive mechanical ventilation during ICU length of stay	up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
Secondary	Acute renal failure	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	up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
Secondary	Hospital length of stay	Hospital length of stay - ICU admission through hospital discharge	up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
Secondary	ICU mortality	Occurence of death during ICU stay	up to 90 days. ICU admission through until death if occured