NCT05587686

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:

  1. 1.Assess whether ventilatory settings after intubation are appropriate.
  2. 2.To compare the ventilatory adjustments made by clinicians with those proposed by the VentilO appalication.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Dec 2022Dec 2026

First Submitted

Initial submission to the registry

October 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

December 5, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

3.5 years

First QC Date

October 17, 2022

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • acid-base abnormalities on arterial (or capillary) 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(or capillary) blood gases after intubation; 2 hours maximum post intubation

  • Improvement acid-base abnormalities with the VentilO application

    * In case of respiratory acidosis: minute ventilation proposed by VentilO \> set minute ventilation; * In case of respiratory alkalosis: proposed minute ventilation by VentilO \< set minute ventilation

    on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation

  • Impairement acid-base abnormalities with the VentilO application

    * In case of respiratory acidosis: proposed minute ventilation by VentilO \< set minute ventilation * In case of respiratory alkalosis: minute ventilation proposed by VentilO \> set minute ventilation

    on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation

Secondary Outcomes (6)

  • Occurence of optimal arterial (or capillary) blood gases result

    on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation

  • Severity of unbalance of arterial (or capillary) blood gases result

    on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation

  • hemodynamic instabilities

    Between Hour0 to Hour1 after intubation

  • ICU length of stay

    up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured

  • Hospital length of stay

    up to 90 days. ICU stay - Emergency department admission through hospital discharge or until death if occured

  • +1 more secondary outcomes

Study Arms (1)

Intubated patient during their stay in the IUCPQ-UL emergency or intensive care department

Other: VentilO application

Interventions

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 appllication we will compare the recommended settings (for mechanical ventilation) vs the real clinicial settings done by clinician after patient intubation.We will evaluated the potential effect of the VentilO recommendation on the first arterial (or capillary) blood gases compared to the real settings.

Intubated patient during their stay in the IUCPQ-UL emergency or intensive care department

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intubated patients during their stay in the IUCPQ-UL emergency or intensive care department

You may qualify if:

  • Adults (\> or = 18 years old)
  • New endotracheal intubation

You may not qualify if:

  • Absence of arterial (or capillary) gas within two hours of intubation
  • Absence of patient sizes available throughout the medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 20, 2022

Study Start

December 5, 2022

Primary Completion

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations