Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
- Conditions
- ICU Acquired Weakness
- Interventions
- Procedure: Protocolized early mobilization in ICU
- Registration Number
- NCT02520193
- Lead Sponsor
- University Hospital, Angers
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 772
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description protocolized early mobilization strategy Protocolized early mobilization in ICU -
- Primary Outcome Measures
Name Time Method Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation 28 days after intubation
- Secondary Outcome Measures
Name Time Method Place where the patient is transferred at the end of the hospital stay End of hospital stay, an expected average of 20 days Time between intubation and the first stand-up position in days 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 end of Intensive Care Unit stay, an expected average of 10 days ICU stay duration end of Intensive Care Unit stay, an expected average of 10 days The incidence of Intensive Care Unit-acquired weakness with Manual Muscle Testing (MMT) scale 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 end of Intensive Care Unit stay, an expected average of 10 days The incidence of delirium with CAM-ICU scale end of Intensive Care Unit stay, an expected average of 10 days Hospital stay duration 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 End of Intensive Care Unit stay, an expected average of 10 days
Trial Locations
- Locations (23)
Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital Rangueil
🇫🇷Toulouse, France
Cliniques Universitaires Saint-Luc - Service des soins intensifs
🇧🇪Bruxelles, Belgium
CHU Angers - Service de Réanimation Médicale et de Médecine Hyperbare
🇫🇷Angers, France
CHU de Brest - Service de réanimation médicale
🇫🇷Brest, France
AP-HP Hôpital Henri Mondor - Service de Réanimation Médicale
🇫🇷Creteil, France
CH de Pontoise - Serive de réanimation médicale - CH René Dubos
🇫🇷Cergy Pontoise, France
CHD Vendée - Service de Réanimation Polyvalente
🇫🇷La Roche Sur Yon, France
Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalente
🇫🇷La Rochelle, France
Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicale
🇫🇷Le Mans, France
CHU Grenoble - Service de Réanimation Médicale - Hôpital A, Michallon
🇫🇷La Tronche, France
CHRU de Lille - Pôle de réanimation -Hôpital Roger Salengro
🇫🇷Lille, France
CH St Joseph St Luc - Service de Réanimation Polyvalente
🇫🇷Lyon, France
Groupe Hospitalier du Havre - Service de Réanimation médico-chirurgicale - Hôpital Jacques Monod
🇫🇷Montivilliers, France
CHU de Nantes - Service de Réanimation Médicale Polyvalente
🇫🇷Nantes, France
CHU de Nice - Service de réanimation médicale - Hôpital de l'Archet
🇫🇷Nice, France
AP-HP Hôpital Tenon - Service de Réanimation
🇫🇷Paris, France
AP-HP Hôpitaux Universitaires Paris Ouest- Service de réanimation médicale - Hôpital Européen Georges Pompidou
🇫🇷Paris, France
CHU Toulouse - service de néphrologie Hémodialyse HTA Transplantation d'Organes - Hôpital Rangueil
🇫🇷Toulouse, France
Hôpital Erasme
🇧🇪Bruxelles, Belgium
CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques
🇧🇪Liege, Belgium
CHU de Liege - Service de soins intensifs généraux
🇧🇪Liege, Belgium
Cliniques Universitaires UCL de Mont-Godinne - Service intensifs généraux
🇧🇪Yvoir, Belgium
CHUV
🇨🇭Lausanne, Switzerland