MedTrace Logo

Controlled MAP in the Brain Injury Patient (COMAT Study)

NCT03991052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-05-30

No results posted yet for this study

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

Interventions

DEVICE

EV1000 and closed-loop system

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

DEVICE

Control group

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

Sponsors & Collaborators

Principal Investigators

  • Jacques DURANTEAU, MD, PhD · Bicetre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-18
Primary Completion
2021-07-07
Completion
2021-07-07

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03991052 on ClinicalTrials.gov