Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
NCT ID: NCT02520193
Last Updated: 2017-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
772 participants
INTERVENTIONAL
2015-12-31
2018-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard mobilization strategy
No interventions assigned to this group
protocolized early mobilization strategy
Protocolized early mobilization in ICU
Interventions
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Protocolized early mobilization in ICU
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Locations
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Hôpital Erasme
Brussels, , Belgium
Cliniques Universitaires Saint-Luc - Service des soins intensifs
Brussels, , Belgium
CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques
Liège, , Belgium
CHU de Liege - Service de soins intensifs généraux
Liège, , Belgium
Cliniques Universitaires UCL de Mont-Godinne - Service intensifs généraux
Yvoir, , Belgium
CHU Angers - Service de Réanimation Médicale et de Médecine Hyperbare
Angers, , France
CHU de Brest - Service de réanimation médicale
Brest, , France
CH de Pontoise - Serive de réanimation médicale - CH René Dubos
Cergy-Pontoise, , France
AP-HP Hôpital Henri Mondor - Service de Réanimation Médicale
Créteil, , France
CHD Vendée - Service de Réanimation Polyvalente
La Roche-sur-Yon, , France
Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalente
La Rochelle, , France
CHU Grenoble - Service de Réanimation Médicale - Hôpital A, Michallon
La Tronche, , France
Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicale
Le Mans, , 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
Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital Rangueil
Toulouse, , France
CHUV
Lausanne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Jean-Charles PREISER
Role: primary
Xavier WITTEBOLE
Role: primary
Vincent FRAIPONT
Role: primary
Pierre DAMAS
Role: primary
Geoffrey HORLAIT
Role: primary
Alain MERCAT
Role: primary
Gwenael PRAT
Role: primary
Cédric CLEOPHAX
Role: primary
Keyvan RAZAZI
Role: primary
Isabelle VINATIER
Role: primary
Maxime LELOUP
Role: primary
Nicolas TERZI
Role: primary
Nicolas CHUDEAU
Role: primary
Saad NSEIR
Role: primary
Gael BOURDIN
Role: primary
Mehdi BOUSTA
Role: primary
Christophe GUITTON
Role: primary
Jean DELLAMONICA
Role: primary
Muriel FARTOUKH
Role: primary
Jean Luc DIEHL
Role: primary
Olivier COINTAULT
Role: primary
Stéphanie RUIZ
Role: primary
Other Identifiers
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2015-A00741-48
Identifier Type: OTHER
Identifier Source: secondary_id
PHRIP 2014-01
Identifier Type: -
Identifier Source: org_study_id
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