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Completed

NCT Number: NCT04196738

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

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

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Key information

Conditions

ARDS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital

Angers, 49100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. change of PaO2 (mmHg)

    Time frame: 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 outcomes

  1. -Respiratory rate variability

    Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

    variability of rate (per minute)

  2. -expiratory and inspiratory transpulmonary pressure

    Time frame: 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

    Time frame: 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

    Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

    pH, PaO2, PaCo2 (mmHg)

  5. -Work of breathing (WOB)

    Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

    calculated with esophageal pressure (Kg/m)

  6. -Pressure time product (PTP)

    Time frame: 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

    Time frame: 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

    Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

    intrinsic positive end-expiratory pressure (cm H20)

  9. MAP

    Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

    mean arterial pressure

  10. HR

    Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

    heart rate (beats per minute)

  11. -Respiratory comfort

    Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

    visual analogic scale

  12. -Patient-ventilator asynchronies

    Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

    numbers of asynchronies analyzed on screen

  13. -Tidal volume variability

    Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes

    variability of Tidal volume (mL)

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation: A Physiological Study

Acronym: COMIX-R

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 12, 2019
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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