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Completed

NCT Number: NCT05886413

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

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.

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Key information

Conditions

Mechanical Ventilation Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VentilO application

Other

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.

Primary outcomes

  1. acid-base abnormalities on arterial blood gases

    Time frame: 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 outcomes

  1. Occurence of optimal arterial blood gases result

    Time frame: 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

  2. Severity of unbalance of arterial blood gases result

    Time frame: 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.

  3. hemodynamic instabilities

    Time frame: 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)

  4. ICU length of stay

    Time frame: 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

  5. Mechanical Ventilation duration

    Time frame: 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

  6. Acute renal failure

    Time frame: 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

  7. Hospital length of stay

    Time frame: 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

  8. ICU mortality

    Time frame: up to 90 days. ICU admission through until death if occured

    Occurence of death during ICU stay

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 2, 2023
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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