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

N/AUnknownNCT02520193

University Hospital, Angers772 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

772

Conditions

ICU Acquired Weakness

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

Hôpital Erasme

Brussels, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc - Service des soins intensifs

Brussels, Belgium

RECRUITING

CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques

Liège, Belgium

RECRUITING

CHU de Liege - Service de soins intensifs généraux

Liège, Belgium

Outcomes

Primary Outcomes

Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation

Time frame: 28 days after intubation

Secondary Outcomes

The incidence of Intensive Care Unit-acquired weakness with Manual Muscle Testing (MMT) scale

Time frame: end of Intensive Care Unit stay, an expected average of 10 days

The incidence and stage of pressure ulcers occurring during ICU stay with NPUAP scale

Time frame: end of Intensive Care Unit stay, an expected average of 10 days

The incidence of delirium with CAM-ICU scale

Time frame: end of Intensive Care Unit stay, an expected average of 10 days

Hospital stay duration

Time frame: End of hospital stay, an expected average of 20 days

Place where the patient is transferred at the end of the hospital stay

Time frame: End of hospital stay, an expected average of 20 days

The delay, in number of days between intubation and the first successful spontaneous breathing trial

Time frame: End of Intensive Care Unit stay, an expected average of 10 days

The incidence of extubation failure defined as re-intubation within 72 hours after the first extubation

Time frame: end of Intensive Care Unit stay, an expected average of 10 days

Time between intubation and the first stand-up position in days

Time frame: end of Intensive Care Unit stay, an expected average of 10 days

ICU stay duration

Time frame: end of Intensive Care Unit stay, an expected average of 10 days

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

Overview

Conditions

Interventions

Eligibility

Locations (23)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts