Clinical trial NCT02520193: Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
Official title: Prospective, Randomized, Multi-center Trial to Assess the Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ICU Acquired Weakness
Keywords: Early mobilisation
Invasive ventilation
Ventilator free days
Intensive Care Unit
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-08-11
Enrollment: 772
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation
timeFrame: 28 days after intubation
Secondary outcomes:
measure: The incidence of Intensive Care Unit-acquired weakness with Manual Muscle Testing (MMT) scale
timeFrame: end of Intensive Care Unit stay, an expected average of 10 days
measure: The incidence and stage of pressure ulcers occurring during ICU stay with NPUAP scale
timeFrame: end of Intensive Care Unit stay, an expected average of 10 days
measure: The incidence of delirium with CAM-ICU scale
timeFrame: end of Intensive Care Unit stay, an expected average of 10 days
measure: Hospital stay duration
timeFrame: End of hospital stay, an expected average of 20 days
measure: Place where the patient is transferred at the end of the hospital stay
timeFrame: End of hospital stay, an expected average of 20 days
measure: The delay, in number of days between intubation and the first successful spontaneous breathing trial
timeFrame: End of Intensive Care Unit stay, an expected average of 10 days
measure: The incidence of extubation failure defined as re-intubation within 72 hours after the first extubation
timeFrame: end of Intensive Care Unit stay, an expected average of 10 days
measure: Time between intubation and the first stand-up position in days
timeFrame: end of Intensive Care Unit stay, an expected average of 10 days
measure: ICU stay duration
timeFrame: end of Intensive Care Unit stay, an expected average of 10 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc - Service des soins intensifs
city: Liege
country: Belgium
facility: CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques
city: Liege
country: Belgium
facility: CHU de Liege - Service de soins intensifs généraux
city: Yvoir
country: Belgium
facility: Cliniques Universitaires UCL de Mont-Godinne - Service intensifs généraux
city: Angers
country: France
facility: CHU Angers - Service de Réanimation Médicale et de Médecine Hyperbare
city: Brest
country: France
facility: CHU de Brest - Service de réanimation médicale
city: Cergy Pontoise
country: France
facility: CH de Pontoise - Serive de réanimation médicale - CH René Dubos
city: Creteil
country: France
facility: AP-HP Hôpital Henri Mondor - Service de Réanimation Médicale
city: La Roche Sur Yon
country: France
facility: CHD Vendée - Service de Réanimation Polyvalente
city: La Rochelle
country: France
facility: Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalente
city: La Tronche
country: France
facility: CHU Grenoble - Service de Réanimation Médicale - Hôpital A, Michallon
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicale
city: Lille
country: France
facility: CHRU de Lille - Pôle de réanimation -Hôpital Roger Salengro
city: Lyon
country: France
facility: CH St Joseph St Luc - Service de Réanimation Polyvalente
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre - Service de Réanimation médico-chirurgicale - Hôpital Jacques Monod
city: Nantes
country: France
facility: CHU de Nantes - Service de Réanimation Médicale Polyvalente
city: Nice
country: France
facility: CHU de Nice - Service de réanimation médicale - Hôpital de l'Archet
city: Paris
country: France
facility: AP-HP Hôpital Tenon - Service de Réanimation
city: Paris
country: France
facility: AP-HP Hôpitaux Universitaires Paris Ouest- Service de réanimation médicale - Hôpital Européen Georges Pompidou
city: Toulouse
country: France
facility: CHU Toulouse - service de néphrologie Hémodialyse HTA Transplantation d'Organes - Hôpital Rangueil
city: Toulouse
country: France
facility: Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital Rangueil
city: Lausanne
country: Switzerland
facility: CHUV
Study officials:
References: