Closed-Loop CommunicationCOMATNCT03792581
COntrolled MAp Trauma Brain Injury (COMAT Study)
A study testing EV1000 and closed-loop system in people with Closed-Loop Communication, run by Erasme University Hospital at 1 site in France.
Trial summary
The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in head trauma injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP compared to patients managed without any automated… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Closed-Loop Communication
- What is being tested?
- EV1000 and closed-loop system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 30 Dec 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated
Who cannot join
- Glasgow score >8
- Bilateral mydriasis at the initial management
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualizing Mean Arterial Pressure of Head Trauma Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial
The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in head trauma injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP compared to patients managed without any automated system (manually management)
Read the detailed description
In head trauma patients, the maintenance of MAP within a very narrow range is desired to avoid secondary ischemic diseases. However, the MAP needed to reach can vary over time based on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust vasopressor infusion and/or fluid administration. Using a novel automated system can overcome this issue and may lead to more time in MAP target than the traditional management.
All patients will have the same automated system for fluid administration using the EV1000 monitoring using the AFM mode ( Assisted fluid management). This system will recommend to the clinical when to administer a fluid bolus to optimize SV and SVV. So fluid administration will be standardized in both groups. The only difference will be the management of MAP.
The goal will be to compare a treatment period of at least 3 hours during which the patient will be under continuous noradrenaline infusion. This treatment time should be within the first 48 hours of patient admission in the Intensive care unit.
- Conditions
- Closed-Loop Communication
- Being tested
- EV1000 and closed-loop system
- Medical subject headings
- Teach-Back Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV1000 and closed-loop systemDevice
This system will recommend when patients need fluid or not and adjust vasopressor administration automatically
| Study group | Role | What they receive |
|---|---|---|
| EV1000 monitor | Active comparator | MAP management will be done as usual ( adjustment by nurses) and fluid management will be managed using the EV1000 monitoring device with the automated decision support system Receives: Device: EV1000 and closed-loop system |
| EV1000 monitor + closed-loop system | Experimental | fluid management will be done using the automated decision support system and MAP will be adjusted by the automated closed-loop system for vasopressor administration Receives: Device: EV1000 and closed-loop system |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEAN ARTERIAL PRESSURE (MAP)
time when MAP will be in the predefined range (+/- 5mmHg of the predefined MAP). This target can changed over the 48 hours of patient management due to increased intracranial pressure. This target is predefined by the clinician in charge of the patient and not involved in the study.
Measured: 48 hours post-admission in the intensive care
Secondary outcomes (17)
Hypotension incidence
percentage time spent with MAP is below 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission
Measured: 48 hours post-admission in the intensive care
Hypertension incidence
percentage time spent with MAP is above 5 mmHg of the predefined MAP target (hypotension) at 48 hours post admission
Measured: 48 hours post-admission in the intensive care
Pulsatility index
measure of pulsatility index using the Transcranial doppler ultrasound
Measured: baseline (admission to the intensive care unit)
Pulsatility index
measure of pulsatility index using the Transcranial doppler ultrasound
Measured: 24 hours post-admission to the intensive care unit
Pulsatility index
measure of pulsatility index using the Transcranial doppler ultrasound
Measured: 48 hours post-admission to the intensive care unit
Mean velocity
measure of mean velocity using the Transcranial doppler ultrasound
Measured: baseline (admission to the intensive care unit)
Mean velocity
measure of mean velocity using the Transcranial doppler ultrasound
Measured: 24 hours post-admission to the intensive care unit
Mean velocity
measure of mean velocity using the Transcranial doppler ultrasound
Measured: 48 hours post-admission to the intensive care unit
diastolic velocity
measure of diastolic velocity using the Transcranial doppler ultrasound
Measured: baseline (admission to the intensive care unit)
Diastolic velocity
measure of diastolic velocity using the Transcranial doppler ultrasound
Measured: 24 hours post-admission to the intensive care unit
Diastolic velocity
measure of diastolic velocity using the Transcranial doppler ultrasound
Measured: 48 hours post-admission to the intensive care unit
Fluid received
comparison of amount of fluid received during the first 48 hours post admission
Measured: 48 hours post-admission in the intensive care
Amount of vasopressor
amount of vasopressor received during the first 48 hours post admission
Measured: 48 hours post-admission in the intensive care
Length of stay in the Intensive care unit
comparison of the length of stay in the Intensive care unit between both groups
Measured: 30 days post-admission in the intensive care
Mean arterial pressure (MAP)
MAP over the first 48 hours postadmission in the intensive care
Measured: 48 hours post-admission in the intensive care
Stroke volume
stroke volume over the first 48 hours postadmission in the intensive care
Measured: 48 hours post-admission in the intensive care
cardiac index
cardiac index over the first 48 hours postadmission in the intensive care
Measured: 48 hours post-admission in the intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 Apr 2019 (estimated)
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Why it stopped: The sponsor was not the good one. We will redo the clincal trial gov to be concordant with the actual sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed-Loop CommunicationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Manual versus automated management of MAP
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bicetre Hospital, University of California, Irvine, University of California, Los Angeles
- Responsible party
- Principal investigator, Alexandre Joosten, Erasme University Hospital
- Investigators
- Jacques Duranteau, PhD, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792581
- Sponsor's protocol ID
- 2018-A02976-49
- Acronym
- COMAT
- Status last verified
- May 2019
- First submitted
- 16 Dec 2018
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualizing Mean Arterial Pressure of Head Trauma Injury Patients Using an Novel Automated System for Vasopressor Administration : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03792581
- Acronym / sponsor ID
- COMAT / 2018-A02976-49
- Conditions
- Closed-Loop Communication
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor was not the good one. We will redo the clincal trial gov to be concordant with the actual sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Bicetre Hospital, University of California, Irvine, University of California, Los Angeles
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 3 Jan 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 goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in head trauma injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP compared to patients managed without any automated system (manually management)
Detailed description
In head trauma patients, the maintenance of MAP within a very narrow range is desired to avoid secondary ischemic diseases. However, the MAP needed to reach can vary over time based on intracranial pressure. Additionally, it is well know that the nurses in the Intensive care unit managed multiple patients simultaneously and cannot dedicate 100% of his-her time to adjust vasopressor infusion and/or fluid administration. Using a novel automated system can overcome this issue and may lead to more time in MAP target than the traditional management.
All patients will have the same automated system for fluid administration using the EV1000 monitoring using the AFM mode ( Assisted fluid management). This system will recommend to the clinical when to administer a fluid bolus to optimize SV and SVV. So fluid administration will be standardized in both groups. The only difference will be the management of MAP.
The goal will be to compare a treatment period of at least 3 hours during which the patient will be under continuous noradrenaline infusion. This treatment time should be within the first 48 hours of patient admission in the Intensive care unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Manual versus automated management of MAP
| Arm | Type | Receives |
|---|---|---|
| EV1000 monitor | Active comparator | Device: EV1000 and closed-loop systemMAP management will be done as usual ( adjustment by nurses) and fluid management will be managed using the EV1000 monitoring device with the automated decision support system |
| EV1000 monitor + closed-loop system | Experimental | Device: EV1000 and closed-loop systemfluid management will be done using the automated decision support system and MAP will be adjusted by the automated closed-loop system for vasopressor administration |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Severe Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated
Key exclusion criteria (2 listed)
- Glasgow score >8
- Bilateral mydriasis at the initial management
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 |
|---|---|---|
| EV1000 and closed-loop systemThis system will recommend when patients need fluid or not and adjust vasopressor administration automatically | Device | EV1000 monitor, EV1000 monitor + closed-loop system |
Primary outcome
MEAN ARTERIAL PRESSURE (MAP)
Time frame: 48 hours post-admission in the intensive care
time when MAP will be in the predefined range (+/- 5mmHg of the predefined MAP). This target can changed over the 48 hours of patient management due to increased intracranial pressure. This target is predefined by the clinician in charge of the patient and not involved in the study.
17 secondary outcomes
Hypotension incidence
Time frame: 48 hours post-admission in the intensive care
Hypertension incidence
Time frame: 48 hours post-admission in the intensive care
Pulsatility index
Time frame: baseline (admission to the intensive care unit)
Pulsatility index
Time frame: 24 hours post-admission to the intensive care unit
Pulsatility index
Time frame: 48 hours post-admission to the intensive care unit
Mean velocity
Time frame: baseline (admission to the intensive care unit)
Mean velocity
Time frame: 24 hours post-admission to the intensive care unit
Mean velocity
Time frame: 48 hours post-admission to the intensive care unit
diastolic velocity
Time frame: baseline (admission to the intensive care unit)
Diastolic velocity
Time frame: 24 hours post-admission to the intensive care unit
Diastolic velocity
Time frame: 48 hours post-admission to the intensive care unit
Fluid received
Time frame: 48 hours post-admission in the intensive care
Amount of vasopressor
Time frame: 48 hours post-admission in the intensive care
Length of stay in the Intensive care unit
Time frame: 30 days post-admission in the intensive care
Mean arterial pressure (MAP)
Time frame: 48 hours post-admission in the intensive care
Stroke volume
Time frame: 48 hours post-admission in the intensive care
cardiac index
Time frame: 48 hours post-admission in the intensive care
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Jacques Duranteau, PhD study director
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EV1000 and closed-loop system in people with Closed-Loop Communication, run by Erasme University Hospital 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 14 May 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
MEAN ARTERIAL PRESSURE (MAP) (time frame: 48 hours post-admission in the intensive care). 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 14 May 2019.