NCT04390360

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

4.2 years

First QC Date

April 20, 2020

Last Update Submit

March 8, 2023

Conditions

ARDS, HumanMechanical Ventilation ComplicationHumidifier Lung

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Correlation between PCO2 variation and alveolar ventilation variation

    60 and 90 minutes post intervention

  • Hemodynamic impact vs pH

    Baseline, 30, 60, 90 and 120 minutes post intervention

  • Hemodynamic impact vs pH

    Baseline, 30, 60, 90 and 120 minutes post intervention

  • Hemodynamic impact vs pH

    Baseline, 30, 60, 90 and 120 minutes post intervention

Study Arms (4)

Protective ventilation with HME

OTHER

Protective ventilation + HME

Procedure: Protective ventilation with HME

Protective ventilation with Heated humidifier

OTHER

Protective ventilation + HH

Procedure: Protective ventilation with Heated humidifier

Implementation of protective ventilation

OTHER

Protective ventilation implementation

Procedure: Protective ventilation implementation

Tidal Volume reduction

OTHER

Tidal volume reduction

Procedure: Tidal Volume reduction

Interventions

Protective ventilation implementationPROCEDURE

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

Implementation of protective ventilation
Protective ventilation with HMEPROCEDURE

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 HME
Protective ventilation with Heated humidifierPROCEDURE

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

Protective ventilation with Heated humidifier
Tidal Volume reductionPROCEDURE

n this condition, we will reduce Tidal volume (with smartphone application calculation) to obtain the same alveolar ventilation (PaCO2) obtained on the HME condition

Tidal Volume reduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years old
  • Mechanical ventilation (control,assist control or SIMV mode)
  • haemodynamic stability (vasopressor \< 0.2 ug/kg/min)
  • presence of an Arterial catheter

You may not qualify if:

  • ECMO or anticipate ECMO
  • body temperature \< 36.0 for post operative patient (cardiac surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, G1V4G5, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

François Lellouche

CONTACT

1-418-656-8711Francois.Lellouche@criucpq.ulaval.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2020

First Posted

May 15, 2020

Study Start

November 1, 2019

Primary Completion

December 30, 2023

Study Completion

June 30, 2024

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

CA(1)