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

Sponsor
Laval University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04390360
Collaborator
(none)
20
Enrollment
1
Location
4
Arms
31.9
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Protective ventilation implementation
  • Procedure: Protective ventilation with HME
  • Procedure: Protective ventilation with Heated humidifier
  • Procedure: Tidal Volume reduction
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Nov 1, 2019
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. PaCO2 Variation [60 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

  2. 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

  1. 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

  2. Hemodynamic impact vs pH [Baseline, 30, 60, 90 and 120 minutes post intervention]

    Cardiac echographic measurement (LeftVentricularEjectionFraction) in relation with acidosis status

  3. Hemodynamic impact vs pH [Baseline, 30, 60, 90 and 120 minutes post intervention]

    Cardiac echographic measurement (RightVentricularEjectionFraction) in relation with acidosis status

  4. Hemodynamic impact vs pH [Baseline, 30, 60, 90 and 120 minutes post intervention]

    Cardiac echographic measurement Arterial pulmonary pressure) in relation with acidosis status

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Quebec Canada G1V4G5

Sponsors and Collaborators

  • Laval University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Laval University
ClinicalTrials.gov Identifier:
NCT04390360
Other Study ID Numbers:
  • 21750
First Posted:
May 15, 2020
Last Update Posted:
Mar 8, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Respiratory Distress Syndrome

Study Results

No Results Posted as of Mar 8, 2021