- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05587686
Potential Impact of the Use of the Application VentilO
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
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 intubation are appropriate.
- To compare the ventilatory adjustments made by clinicians with those proposed by the VentilO appalication.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Quebec
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Québec, Quebec, Canada, G1V4G5
- Institut Universitaire de cardiologie et de pneumologie de Quebec
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Intubated patient during their stay in the IUCPQ-UL emergency or intensive care department
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
acid-base abnormalities on arterial (or capillary) blood gases
Time Frame: on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation
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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
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Improvement acid-base abnormalities with the VentilO application
Time Frame: on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation
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on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation
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Impairement acid-base abnormalities with the VentilO application
Time Frame: on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation
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on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occurence of optimal arterial (or capillary) blood gases result
Time Frame: on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation
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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
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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
Time Frame: on the first result available of arterial(or capillary) blood gases after intubation; 2 hours maximum post intubation
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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(or capillary) blood gases after intubation; 2 hours maximum post intubation
|
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hemodynamic instabilities
Time Frame: Between Hour0 to Hour1 after intubation
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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)
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Between Hour0 to Hour1 after intubation
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ICU length of stay
Time Frame: up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
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ICU length of stay - ICU admission through ICU discharge
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up to 90 days. ICU stay - ICU admission through ICU discharge or until death if occured
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Hospital length of stay
Time Frame: up to 90 days. ICU stay - Emergency department admission through hospital discharge or until death if occured
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Hospital length of stay - Emergency department admission through hospital discharge
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up to 90 days. ICU stay - Emergency department admission through hospital discharge or until death if occured
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ICU mortality
Time Frame: up to 90 days. ICU admission through until death if occured
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Occurence of death during ICU stay
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up to 90 days. ICU admission through until death if occured
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22267
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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