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

Not Applicable

Recruiting

• Conditions: Mechanical Ventilation Complication; Humidifier Lung; ARDS, Human
• Interventions: Procedure: Protective ventilation with Heated humidifier; Procedure: Protective ventilation with HME; Procedure: Protective ventilation implementation; Procedure: Tidal Volume reduction

• Registration Number: NCT04390360
• Lead Sponsor: Laval University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10
• Primary Completion: 2023-12-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Protective ventilation with Heated humidifier	Protective ventilation with Heated humidifier	Protective ventilation + HH
Protective ventilation with HME	Protective ventilation with HME	Protective ventilation + HME
Implementation of protective ventilation	Protective ventilation implementation	Protective ventilation implementation
Tidal Volume reduction	Tidal Volume reduction	Tidal volume reduction

Primary Outcome Measures

Name	Time	Method
PaCO2 Variation	120 minutes post intervention	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

Secondary Outcome Measures

Name	Time	Method
Correlation between PCO2 variation and alveolar ventilation variation	60 and 90 minutes post intervention	We will compare PaCO2 level variation and the alveolar ventilation variation to establish correlation.; Correlation variation under 10% will be significative
Hemodynamic impact vs pH	Baseline, 30, 60, 90 and 120 minutes post intervention	Cardiac echographic measurement Arterial pulmonary pressure) in relation with acidosis status

Trial Locations

Locations (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval; 🇨🇦 Quebec, Canada