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

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
ICU Acquired Weakness Procedure: Protocolized early mobilization in ICU Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 772 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective, Randomized, Multi-center Trial to Assess the Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : August 2018
Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard mobilization strategy
Experimental: protocolized early mobilization strategy Procedure: Protocolized early mobilization in ICU


Outcome Measures
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Primary Outcome Measures :
  1. Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation [ Time Frame: 28 days after intubation ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. The incidence of delirium with CAM-ICU scale [ Time Frame: end of Intensive Care Unit stay, an expected average of 10 days ]
  4. Hospital stay duration [ Time Frame: End of hospital stay, an expected average of 20 days ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. ICU stay duration [ Time Frame: end of Intensive Care Unit stay, an expected average of 10 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520193


Contacts
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Contact: Laurent POIROUX ++33 2 41 35 64 40 LaPoiroux@chu-angers.fr
Contact: Lise PIQUILLOUD, MD ++41 79 556 68 27 lise.piquilloud@chuv.ch

Locations
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Sponsors and Collaborators
University Hospital, Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02520193    
Other Study ID Numbers: PHRIP 2014-01
2015-A00741-48 ( Other Identifier: ANSM )
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: July 2016
Keywords provided by University Hospital, Angers:
Early mobilisation
Invasive ventilation
Ventilator free days
Intensive Care Unit
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes