ARDSCOMIX-RNCT04196738
Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation.
A study testing ventilation strategy in people with ARDS, run by University Hospital, Angers at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- ventilation strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2020to 26 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation: A Physiological Study
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
- Being tested
- ventilation strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilation strategyOther
Patients are ventilated in randomised order with three different ventilation strategies: volume assist control (constant flow), Dual Mode or Airway Pressure Released Ventilation
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: ventilation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Secondary outcomes (13)
-Respiratory rate variability
variability of rate (per minute)
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-expiratory and inspiratory transpulmonary pressure
calculated with the esophageal pressure (cm H20)
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-ventilation distribution in the lungs
Electrical impedance tomography (EIT) assess distribution of tidal volume and of end-expiratory lung volume (EELV) (delta Z, IU)
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-other arterial parameters of hematosis
pH, PaO2, PaCo2 (mmHg)
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Work of breathing (WOB)
calculated with esophageal pressure (Kg/m)
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Pressure time product (PTP)
-Pressure time product (PTP) calculated with esophageal pressure (cmH2O.s.min-1)
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-P0.1
pressure measured during the first 100 ms after an occlusion (cm H20)
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-PEEPi
intrinsic positive end-expiratory pressure (cm H20)
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
MAP
mean arterial pressure
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
HR
heart rate (beats per minute)
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Respiratory comfort
visual analogic scale
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Patient-ventilator asynchronies
numbers of asynchronies analyzed on screen
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Tidal volume variability
variability of Tidal volume (mL)
Measured: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start30 Jun 2020
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- patients exposed to 3 ventilatory mode in 2 different possible orders
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Francois BELONCLE, CCU-AH, Principal investigator, Angers teatching hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196738
- Sponsor's protocol ID
- 49RC19_0195
- Acronym
- COMIX-R
- Status last verified
- Jan 2024
- First submitted
- 12 Nov 2019
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Volume Assist Control, Dual Mode and Airway Pressure Release Ventilation: A Physiological Study
- ClinicalTrials.gov ID
- NCT04196738
- Acronym / sponsor ID
- COMIX-R / 49RC19_0195
- Conditions
- ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients exposed to 3 ventilatory mode in 2 different possible orders
| Arm | Type | Receives |
|---|---|---|
| Dual Mode first | Experimental | Other: ventilation strategyFour consecutive steps (45 min per step) in the following order: APRV (A), Dual Mode (B) , APRV (A) and VAC (C). (ABAC) |
| VAC fist | Experimental | Other: ventilation strategyFour consecutive steps (45 min per step) in the following order: APRV (A), VAC (C) , APRV (A) and Dual Mode (B). (ACAB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventilation strategyPatients are ventilated in randomised order with three different ventilation strategies: volume assist control (constant flow), Dual Mode or Airway Pressure Released Ventilation | Other | Dual Mode first, VAC fist |
Primary outcome
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.
13 secondary outcomes
-Respiratory rate variability
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-expiratory and inspiratory transpulmonary pressure
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-ventilation distribution in the lungs
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-other arterial parameters of hematosis
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Work of breathing (WOB)
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Pressure time product (PTP)
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-P0.1
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-PEEPi
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
MAP
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
HR
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Respiratory comfort
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Patient-ventilator asynchronies
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
-Tidal volume variability
Time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois BELONCLE, CCU-AH principal investigator
Angers teatching hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilation strategy in people with ARDS, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of PaO2 (mmHg) (time frame: 15 minutes, 1 hour, 1hour and 45 minutes, 2 hour and 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.