Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients (EarlyMob)

University Hospital, Angers

Status

Unknown

Conditions

ICU Acquired Weakness

Treatments

Procedure: Protocolized early mobilization in ICU

Study type

Interventional

Funder types

Other

Identifiers

NCT02520193

2015-A00741-48 (Other Identifier)

PHRIP 2014-01

Details and patient eligibility

About

The purpose of the present study is to compare usual care in terms of mobilization performed to intubated ICU patients to a standardized program designed to deliver early mobilization at least 5 days a week.

This study has a before / after design with a control group during the experimental phase. The first phase of the study corresponds to an observational phase during which every act of mobilization performed to the included patients is going to be documented. During this first study period, total duration of mechanical ventilation is going to be recorded for all the patients included.

At the end of this first study period, the participating ICU are going to be randomized (Cluster randomization) in two groups either observational or experimental. The corresponding strategy is going to be applied to all the patients included during the second study period. During this second period, total duration of mechanical ventilation is also going to be recorded for all the patients included.

The study hypothesis is that applying a protocolized early mobilization strategy increases the number of ventilator free-days during the 28 days after intubation in ICU patients.

Enrollment

772 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Admission in intensive care unit
Invasive ventilation for more than 24 hours
Invasive ventilation for less than 48 hours
Expected duration of invasive ventilation of more than 24 hours at the time of inclusion.

Exclusion criteria

Pregnancy
Failure to obtain a consent from someone authorized
Patient under law protection.
Patient non-affiliated to a health care system.
Active therapeutic limitation
Hospitalisation for more than 7 days before intubation
Admission in intensive care unit after a surgical procedure, burn or trauma
Admission in intensive care unit because of neurological disease
Previously known neuromuscular disease
Bilateral lower limbs amputation
BMI above 40 kg/m²
Limitation in daily activities before ICU admission
Chronic ventilation (more than 12h /24 hours) on tracheotomy before ICU admission
Participation in another interventional clinical study related to mobilization or in an interventional clinical study which has mechanical ventilation duration as primary outcome
Previous enrolment in the same phase of the EarlyMob study