Potential Impact of the Use of the Application VentilO

Sponsor
Laval University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05587686
Collaborator
(none)
100
1
12
8.3

Study Details

Study Description

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. Assess whether ventilatory settings after intubation are appropriate.

  2. To compare the ventilatory adjustments made by clinicians with those proposed by the VentilO appalication.

Condition or Disease Intervention/Treatment Phase
  • Other: VentilO application

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Frequency of Respiratory Acidosis and Alkalosis in the Emergency and Intensive Care Department of the IUCPQ-UL. Potential Impact of the Use of the Application VentilO
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Intubated patient during their stay in the IUCPQ-UL emergency or intensive care department

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 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.

Outcome Measures

Primary Outcome Measures

  1. acid-base abnormalities on arterial (or capillary) blood gases [on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation]

    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)

  2. Improvement acid-base abnormalities with the VentilO application [on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation]

    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

  3. Impairement acid-base abnormalities with the VentilO application [on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation]

    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

Secondary Outcome Measures

  1. 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]

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

    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 [Between Hour0 to Hour1 after intubation]

    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 [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. Hospital length of stay [up to 90 days. ICU stay - Emergency department admission through hospital discharge or until death if occured]

    Hospital length of stay - Emergency department admission through hospital discharge

  6. ICU mortality [up to 90 days. ICU admission through until death if occured]

    Occurence of death during ICU stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adults (> or = 18 years old)

  • New endotracheal intubation

Exclusion Criteria:
  • Absence of arterial (or capillary) gas within two hours of intubation

  • Absence of patient sizes available throughout the medical record

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Universitaire de Cardiologie et de Pneumologie de Québec Quebec Canada G1V4G5

Sponsors and Collaborators

  • Laval University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
François Lellouche, Principal Investigator, Laval University
ClinicalTrials.gov Identifier:
NCT05587686
Other Study ID Numbers:
  • 22267
First Posted:
Oct 20, 2022
Last Update Posted:
Oct 20, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 20, 2022