Controlled MAP in the Brain Injury Patient (COMAT Study)

NCT03991052 | Completed

• 1 other identifier: APHP180501
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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 brain injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP (+/- 5 mmHg of the target MAP) compared to patients managed without any automated system (manually management)

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (1)

• Mean arterial pressure (MAP)

  percentage of treatment time when MAP will be in the predefined range (+/- 5 mmHg of the target MAP)

  48 hours post-admission in the intensive care unit

Secondary Outcomes (12)

• Percentage of case time spent in Hypotension

  48 hours post-admission in the intensive care unit

• Percentage of case time spent Hypertension

  48 hours post-admission in the intensive care unit

• Cerebral perfusion pressure

  48 hours post-admission in the intensive care unit

• Intracranial pressure

  48 hours post-admission in the intensive care unit

• Intracranial pressure Hypertension

  48 hours post-admission in the intensive care unit

Study Arms (2)

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

Device: Control group

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

Device: EV1000 and closed-loop system

Interventions

EV1000 and closed-loop system DEVICE

This system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system

EV1000 monitor + closed-loop system

Control group DEVICE

This system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care)

EV1000 monitor

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severe brain injury patients (Glasgow score \<9), intubated, ventilated and sedated.

You may not qualify if:

• Glasgow score \> 8
• Bilateral mydriasis at the initial management (Ambulance and first hour of arrival)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• University of California, Los Angeles: collaborator
• University of California, Irvine: collaborator

Study Sites (1)

Bicêtre hospital

Le Kremlin-Bicêtre, 94270, France

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jacques DURANTEAU, MD, PhD

  Bicetre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: manual versus automated management of MAP

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 19, 2019
• Study Start: December 18, 2019
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)