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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
772

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
          • Gwénaël 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard mobilization strategy
Experimental: protocolized early mobilization strategy
Procedure: Protocolized early mobilization in ICU

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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