COntrolled MAp Trauma Brain Injury (COMAT Study)

NCT03792581 | Withdrawn

• 1 other identifier: 2018-A02976-49
• Study Type: interventional
• Target: N/A
• 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 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)

Conditions

Closed-Loop Communication

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours post-admission in the intensive care

Secondary Outcomes (17)

• Hypotension incidence

  48 hours post-admission in the intensive care

• Hypertension incidence

  48 hours post-admission in the intensive care

• Pulsatility index

  baseline (admission to the intensive care unit)

• Pulsatility index

  24 hours post-admission to the intensive care unit

• Pulsatility index

  48 hours post-admission to 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: 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

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

EV1000 monitor; EV1000 monitor + closed-loop system

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 Head trauma Patients ( Glasgow score ≤8), intubated, ventilated and sedated

You may not qualify if:

• Glasgow score \>8
• Bilateral mydriasis at the initial management

Sponsors & Collaborators

• Erasme University Hospital: lead
• Bicetre Hospital: collaborator
• University of California, Irvine: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Joosten Alexandre

Paris, LE Kremlin Bicetre, 94275, France

Location

MeSH Terms

Conditions

Teach-Back Communication

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Jacques Duranteau, PhD

  APHP

  STUDY DIRECTOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Manual versus automated management of MAP

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: January 3, 2019
• Study Start: April 1, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

FR (1)