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

NCT04196738 | Completed

• 1 other identifier: 49RC19_0195
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ARDS

Outcome Measures

Primary Outcomes (1)

• change of PaO2 (mmHg)

  Arterial partial pressure of dioxygen Of note: As it is a physiological study, all the primary and secondary outcomes will be analyzed with the same importance.

  15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

Secondary Outcomes (13)

• -Respiratory rate variability

  15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

• -expiratory and inspiratory transpulmonary pressure

  15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

• -ventilation distribution in the lungs

  15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

• -other arterial parameters of hematosis

  15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

• -Work of breathing (WOB)

  15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

Study Arms (2)

Dual Mode first

EXPERIMENTAL

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

Other: ventilation strategy

VAC fist

EXPERIMENTAL

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

Other: ventilation strategy

Interventions

ventilation strategy OTHER

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

Dual Mode first; VAC fist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University hospital

Angers, 49100, France

Location

Study Officials

• Francois BELONCLE, CCU-AH

  Angers teatching hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: patients exposed to 3 ventilatory mode in 2 different possible orders

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: December 12, 2019
• Study Start: June 30, 2020
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: January 9, 2024

Record last verified: 2024-01

Locations

FR (1)