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

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

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation Complication; ARDS, Human; Humidifier Lung
• Intervention / Treatment: Procedure: Protective ventilation with HME; Procedure: Protective ventilation with Heated humidifier; Procedure: Protective ventilation implementation; Procedure: Tidal Volume reduction

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francois Lellouche; Phone Number: 1-418-656-8711; Email: francois.lellouche@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec, Canada, G1V4G5
    • Recruiting
    • Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Protective ventilation with HME; Protective ventilation + HME	Procedure: 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
Other: Protective ventilation with Heated humidifier; Protective ventilation + HH	Procedure: 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
Other: Implementation of protective ventilation; Protective ventilation implementation	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
Other: Tidal Volume reduction; Tidal volume reduction	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Hemodynamic impact vs pH	Cardiac echographic measurement (LeftVentricularEjectionFraction) in relation with acidosis status	Baseline, 30, 60, 90 and 120 minutes post intervention
Hemodynamic impact vs pH	Cardiac echographic measurement (RightVentricularEjectionFraction) in relation with acidosis status	Baseline, 30, 60, 90 and 120 minutes post intervention
Hemodynamic impact vs pH	Cardiac echographic measurement Arterial pulmonary pressure) in relation with acidosis status	Baseline, 30, 60, 90 and 120 minutes post intervention

Collaborators and Investigators

• Sponsor: Laval University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 15, 2020

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Distress Syndrome
• Other Study ID Numbers: 21750 (Stanford IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No