Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction

Mechanical Ventilation Complication Clinical Trial

— Ventilo  

Official title:

Development and Evaluation of Smartphone App for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction on Physiologic Parameter Based on the Smartphone App

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04390360
• Other study ID #: 21750
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• ARDS, Human
• Humidifier Lung
• Mechanical Ventilation Complication
• Respiratory Distress Syndrome

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