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

May 4, 2017 updated by: University Hospital, Angers

Prospective, Randomized, Multi-center Trial to Assess the Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

772

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1070
        • Recruiting
        • Hopital Erasme
        • Contact:
          • Jean-Charles Preiser
      • Bruxelles, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc - Service des soins intensifs
        • Contact:
          • Xavier WITTEBOLE
      • Liege, Belgium, 4000
        • Recruiting
        • CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques
        • Contact:
          • Vincent Fraipont
      • Liege, Belgium, 4000
        • Recruiting
        • CHU de Liege - Service de soins intensifs généraux
        • Contact:
          • Pierre DAMAS
      • Yvoir, Belgium, 5530
        • Recruiting
        • Cliniques Universitaires UCL de Mont-Godinne - Service intensifs généraux
        • Contact:
          • Geoffrey HORLAIT
  • France
      • Angers, France, 49100
        • Recruiting
        • CHU Angers - Service de Réanimation Médicale et de Médecine Hyperbare
        • Contact:
          • Alain MERCAT
      • Brest, France, 29609
        • Recruiting
        • CHU de Brest - Service de réanimation médicale
        • Contact:
          • Gwenael PRAT
      • Cergy Pontoise, France, 95303
        • Recruiting
        • CH de Pontoise - Serive de réanimation médicale - CH René Dubos
        • Contact:
          • Cédric CLEOPHAX
      • Creteil, France, 94010
        • Recruiting
        • AP-HP Hôpital Henri Mondor - Service de Réanimation Médicale
        • Contact:
          • Keyvan RAZAZI
      • La Roche Sur Yon, France, 85925
        • Recruiting
        • CHD Vendée - Service de Réanimation Polyvalente
        • Contact:
          • Isabelle VINATIER
      • La Rochelle, France, 17000
        • Recruiting
        • Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalente
        • Contact:
          • Maxime LELOUP
      • La Tronche, France, 38700
        • Recruiting
        • CHU Grenoble - Service de Réanimation Médicale - Hôpital A, Michallon
        • Contact:
          • Nicolas TERZI
      • Le Mans, France, 72037
        • Recruiting
        • Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicale
        • Contact:
          • Nicolas CHUDEAU
      • Lille, France, 59037
        • Recruiting
        • CHRU de Lille - Pôle de réanimation -Hôpital Roger Salengro
        • Contact:
          • Saad NSEIR
      • Lyon, France, 69007
        • Recruiting
        • CH St Joseph St Luc - Service de Réanimation Polyvalente
        • Contact:
          • Gael BOURDIN
      • Montivilliers, France, 76290
        • Recruiting
        • Groupe Hospitalier du Havre - Service de Réanimation médico-chirurgicale - Hôpital Jacques Monod
        • Contact:
          • Mehdi BOUSTA
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes - Service de Réanimation Médicale Polyvalente
        • Contact:
          • Christophe GUITTON
      • Nice, France, 06202
        • Recruiting
        • CHU de Nice - Service de réanimation médicale - Hôpital de l'Archet
        • Contact:
          • Jean DELLAMONICA
      • Paris, France, 75020
        • Recruiting
        • AP-HP Hôpital Tenon - Service de Réanimation
        • Sub-Investigator:
          • Tai PHAM
      • Paris, France, 75908
        • Recruiting
        • AP-HP Hôpitaux Universitaires Paris Ouest- Service de réanimation médicale - Hôpital Européen Georges Pompidou
        • Contact:
          • Jean Luc DIEHL
      • Toulouse, France, 31059
        • Recruiting
        • CHU Toulouse - service de néphrologie Hémodialyse HTA Transplantation d'Organes - Hôpital Rangueil
        • Contact:
          • Olivier COINTAULT
      • Toulouse, France, 31059
        • Recruiting
        • Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital Rangueil
        • Contact:
          • Stéphanie RUIZ
  • Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard mobilization strategy
Experimental: protocolized early mobilization strategy
Procedure: Protocolized early mobilization in ICU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation
Time Frame: 28 days after intubation
28 days after intubation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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
end of Intensive Care Unit stay, an expected average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

July 28, 2015

First Submitted That Met QC Criteria

August 10, 2015

First Posted (Estimate)

August 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRIP 2014-01
  • 2015-A00741-48 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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