search
Back to results

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

Primary Purpose

ARDS, Human, Mechanical Ventilation Complication, Humidifier Lung

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Protective ventilation implementation
Protective ventilation with HME
Protective ventilation with Heated humidifier
Tidal Volume reduction
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ARDS, Human

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Institut universitaire de cardiologie et de pneumologie de Québec - Université LavalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Protective ventilation with HME

Protective ventilation with Heated humidifier

Implementation of protective ventilation

Tidal Volume reduction

Arm Description

Protective ventilation + HME

Protective ventilation + HH

Protective ventilation implementation

Tidal volume reduction

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
Hemodynamic impact vs pH
Cardiac echographic measurement (LeftVentricularEjectionFraction) in relation with acidosis status
Hemodynamic impact vs pH
Cardiac echographic measurement (RightVentricularEjectionFraction) in relation with acidosis status
Hemodynamic impact vs pH
Cardiac echographic measurement Arterial pulmonary pressure) in relation with acidosis status

Full Information

First Posted
April 20, 2020
Last Updated
March 8, 2023
Sponsor
Laval University
search

1. Study Identification

Unique Protocol Identification Number
NCT04390360
Brief Title
Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Human, Mechanical Ventilation Complication, Humidifier Lung

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Protective ventilation with HME
Arm Type
Other
Arm Description
Protective ventilation + HME
Arm Title
Protective ventilation with Heated humidifier
Arm Type
Other
Arm Description
Protective ventilation + HH
Arm Title
Implementation of protective ventilation
Arm Type
Other
Arm Description
Protective ventilation implementation
Arm Title
Tidal Volume reduction
Arm Type
Other
Arm Description
Tidal volume reduction
Intervention Type
Procedure
Intervention Name(s)
Protective ventilation implementation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Protective ventilation with HME
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Protective ventilation with Heated humidifier
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Tidal Volume reduction
Intervention Description
n this condition, we will reduce Tidal volume (with smartphone application calculation) to obtain the same alveolar ventilation (PaCO2) obtained on the HME condition
Primary Outcome Measure Information:
Title
PaCO2 Variation
Description
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
Time Frame
60 minutes post intervention
Title
PaCO2 Variation
Description
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
Time Frame
120 minutes post intervention
Secondary Outcome Measure Information:
Title
Correlation between PCO2 variation and alveolar ventilation variation
Description
We will compare PaCO2 level variation and the alveolar ventilation variation to establish correlation. Correlation variation under 10% will be significative
Time Frame
60 and 90 minutes post intervention
Title
Hemodynamic impact vs pH
Description
Cardiac echographic measurement (LeftVentricularEjectionFraction) in relation with acidosis status
Time Frame
Baseline, 30, 60, 90 and 120 minutes post intervention
Title
Hemodynamic impact vs pH
Description
Cardiac echographic measurement (RightVentricularEjectionFraction) in relation with acidosis status
Time Frame
Baseline, 30, 60, 90 and 120 minutes post intervention
Title
Hemodynamic impact vs pH
Description
Cardiac echographic measurement Arterial pulmonary pressure) in relation with acidosis status
Time Frame
Baseline, 30, 60, 90 and 120 minutes post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Lellouche
Phone
1-418-656-8711
Email
Francois.Lellouche@criucpq.ulaval.ca
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
City
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Alexandre Bouchard
Phone
418-656-8711
Ext
2712
Email
pierre-alexandre.bouchard@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Francois Lellouche

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs