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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04390360
Other study ID # 21750
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date June 30, 2024

Study information

Verified date March 2023
Source Laval University
Contact François Lellouche
Phone 1-418-656-8711
Email Francois.Lellouche@criucpq.ulaval.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Clinical evaluation of a new educative tools (Smartphone application) based on impact of instrumental dead space reduction after initiation of protective ventilation during mechanical ventilation.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age > 18 years old - Mechanical ventilation (control,assist control or SIMV mode) - haemodynamic stability (vasopressor < 0.2 ug/kg/min) - no prone position schedule in the next 2 hours following procedure inclusion - presence of an Arterial catheter Exclusion Criteria: - ECMO or anticipate ECMO - body temperature < 36.0 for post operative patient (cardiac surgery)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Protective ventilation implementation
In this condition, we will implement the protective ventilation related with gender and height . A blood gas will be performed at before protective ventilation implementation and at the end of this condition.Time condition 30 minutes
Protective ventilation with HME
In this condition, the patient will received protective ventilation with a Heat Moisture Exchanger (HME). A blood gas will be performed at the end of this condition.Time condition 30 minutes
Protective ventilation with Heated humidifier
In this condition, the patient will received protective ventilation with a Heated humidifier. A blood gas will be performed at the end of this condition.Time condition 30 minutes
Tidal Volume reduction
n this condition, we will reduce Tidal volume (with smartphone application calculation) to obtain the same alveolar ventilation (PaCO2) obtained on the HME condition

Locations

Country Name City State
Canada Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Quebec

Sponsors (1)

Lead Sponsor Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary PaCO2 Variation The primary outcome is to evaluate the PaCO2 variation at the end of condition 2 (after 30 minutes with protective ventilation+ HME) and condition 4 (30 minutes after Tidal volume reduction + Heater humidifier).
Variation <= 10% of PaCO2
60 minutes post intervention
Primary PaCO2 Variation The primary outcome is to evaluate the PaCO2 variation at the end of condition 2 (after 30 minutes with protective ventilation+ HME) and condition 4 (30 minutes after Tidal volume reduction + Heater humidifier).
Variation <= 10% of PaCO2
120 minutes post intervention
Secondary Correlation between PCO2 variation and alveolar ventilation variation We will compare PaCO2 level variation and the alveolar ventilation variation to establish correlation.
Correlation variation under 10% will be significative
60 and 90 minutes post intervention
Secondary Hemodynamic impact vs pH Cardiac echographic measurement (LeftVentricularEjectionFraction) in relation with acidosis status Baseline, 30, 60, 90 and 120 minutes post intervention
Secondary Hemodynamic impact vs pH Cardiac echographic measurement (RightVentricularEjectionFraction) in relation with acidosis status Baseline, 30, 60, 90 and 120 minutes post intervention
Secondary Hemodynamic impact vs pH Cardiac echographic measurement Arterial pulmonary pressure) in relation with acidosis status Baseline, 30, 60, 90 and 120 minutes post intervention
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