Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02520193
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : August 11, 2015
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Tracking Information
First Submitted Date  ICMJE July 28, 2015
First Posted Date  ICMJE August 11, 2015
Last Update Posted Date May 5, 2017
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2015)
Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation [ Time Frame: 28 days after intubation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
Official Title  ICMJE Prospective, Randomized, Multi-center Trial to Assess the Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE ICU Acquired Weakness
Intervention  ICMJE Procedure: Protocolized early mobilization in ICU
Study Arms  ICMJE
  • No Intervention: Standard mobilization strategy
  • Experimental: protocolized early mobilization strategy
    Intervention: Procedure: Protocolized early mobilization in ICU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 10, 2015)
772
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02520193
Other Study ID Numbers  ICMJE PHRIP 2014-01
2015-A00741-48 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Angers
Study Sponsor  ICMJE University Hospital, Angers
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Angers
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP