Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation.

NCT ID: NCT04196738

Last Updated: 2024-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2022-10-26

Brief Summary

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The aim of the COMIX-R study is to assess the short term physiological effects of 3 ventilation strategies for adult patients with ARDS admitted to intensive care unit

Detailed Description

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Conditions

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ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

patients exposed to 3 ventilatory mode in 2 different possible orders
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Dual Mode first

Four consecutive steps (45 min per step) in the following order: APRV (A), Dual Mode (B) , APRV (A) and VAC (C). (ABAC)

Group Type EXPERIMENTAL

ventilation strategy

Intervention Type OTHER

Patients are ventilated in randomised order with three different ventilation strategies: volume assist control (constant flow), Dual Mode or Airway Pressure Released Ventilation

VAC fist

Four consecutive steps (45 min per step) in the following order: APRV (A), VAC (C) , APRV (A) and Dual Mode (B). (ACAB)

Group Type EXPERIMENTAL

ventilation strategy

Intervention Type OTHER

Patients are ventilated in randomised order with three different ventilation strategies: volume assist control (constant flow), Dual Mode or Airway Pressure Released Ventilation

Interventions

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ventilation strategy

Patients are ventilated in randomised order with three different ventilation strategies: volume assist control (constant flow), Dual Mode or Airway Pressure Released Ventilation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Invasive mechanical ventilation on tracheal probe
* Acute respiratory distress syndrome, as defined by Berlin conference consensus, during hospitalization in intensive care,
* Recovery phase of acute respiratory distress syndrome: spontaneous ventilation representing from 20 to 30% of ventilation in APRV mode.
* No severe acidosis (pH\> 7.30)
* Patient affiliated to or beneficiary of a health care plan
* Express consent of the patient or his/her SDM

Exclusion Criteria

* Pneumothorax
* Contraindication to the insertion of a nasogastric tube with an esophageal balloon
* Contraindication to the use of Electrical impedance tomography (pacemaker)
* Pregnancy, lactating or parturient woman
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francois BELONCLE, CCU-AH

Role: PRINCIPAL_INVESTIGATOR

Angers teatching hospital

Locations

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University hospital

Angers, , France

Site Status

Countries

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France

Other Identifiers

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49RC19_0195

Identifier Type: -

Identifier Source: org_study_id

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