COMIX-R: Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation.

• Sponsor: University Hospital, Angers (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04196738
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
ARDS	Other: ventilation strategy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: patients exposed to 3 ventilatory mode in 2 different possible orderspatients exposed to 3 ventilatory mode in 2 different possible orders
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation: A Physiological Study
• Actual Study Start Date: Jun 30, 2020
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Other: 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
Experimental: VAC fist 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; Patients are ventilated in randomised order with three different ventilation strategies: volume assist control (constant flow), Dual Mode or Airway Pressure Released Ventilation

Outcome Measures

Primary Outcome Measures

1. change of PaO2 (mmHg) [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

   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.

Secondary Outcome Measures

1. -Respiratory rate variability [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

   variability of rate (per minute)

2. -expiratory and inspiratory transpulmonary pressure [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

   calculated with the esophageal pressure (cm H20)

3. -ventilation distribution in the lungs [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

   Electrical impedance tomography (EIT) assess distribution of tidal volume and of end-expiratory lung volume (EELV) (delta Z, IU)

4. -other arterial parameters of hematosis [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

   pH, PaO2, PaCo2 (mmHg)

5. -Work of breathing (WOB) [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

   calculated with esophageal pressure (Kg/m)

6. -Pressure time product (PTP) [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

   -Pressure time product (PTP) calculated with esophageal pressure (cmH2O.s.min-1)

7. -P0.1 [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

   pressure measured during the first 100 ms after an occlusion (cm H20)

8. -PEEPi [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

   intrinsic positive end-expiratory pressure (cm H20)

9. MAP [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

   mean arterial pressure

10. HR [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

    heart rate (beats per minute)

11. -Respiratory comfort [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

    visual analogic scale

12. -Patient-ventilator asynchronies [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

    numbers of asynchronies analyzed on screen

13. -Tidal volume variability [15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes]

    variability of Tidal volume (mL)

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital	Angers		France	49100

Sponsors and Collaborators

• University Hospital, Angers

Investigators

• Principal Investigator: Francois BELONCLE, CCU-AH, Angers teatching hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT04196738
• Other Study ID Numbers: 49RC19_0195
• First Posted: Dec 12, 2019
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 28, 2022