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

Primary Purpose

ICU Acquired Weakness

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Protocolized early mobilization in ICU
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ICU Acquired Weakness focused on measuring Early mobilisation, Invasive ventilation, Ventilator free days, Intensive Care Unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital ErasmeRecruiting
  • Cliniques Universitaires Saint-Luc - Service des soins intensifsRecruiting
  • CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriquesRecruiting
  • CHU de Liege - Service de soins intensifs générauxRecruiting
  • Cliniques Universitaires UCL de Mont-Godinne - Service intensifs générauxRecruiting
  • CHU Angers - Service de Réanimation Médicale et de Médecine HyperbareRecruiting
  • CHU de Brest - Service de réanimation médicaleRecruiting
  • CH de Pontoise - Serive de réanimation médicale - CH René DubosRecruiting
  • AP-HP Hôpital Henri Mondor - Service de Réanimation MédicaleRecruiting
  • CHD Vendée - Service de Réanimation PolyvalenteRecruiting
  • Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalenteRecruiting
  • CHU Grenoble - Service de Réanimation Médicale - Hôpital A, MichallonRecruiting
  • Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicaleRecruiting
  • CHRU de Lille - Pôle de réanimation -Hôpital Roger SalengroRecruiting
  • CH St Joseph St Luc - Service de Réanimation PolyvalenteRecruiting
  • Groupe Hospitalier du Havre - Service de Réanimation médico-chirurgicale - Hôpital Jacques MonodRecruiting
  • CHU de Nantes - Service de Réanimation Médicale PolyvalenteRecruiting
  • CHU de Nice - Service de réanimation médicale - Hôpital de l'ArchetRecruiting
  • AP-HP Hôpital Tenon - Service de RéanimationRecruiting
  • AP-HP Hôpitaux Universitaires Paris Ouest- Service de réanimation médicale - Hôpital Européen Georges PompidouRecruiting
  • CHU Toulouse - service de néphrologie Hémodialyse HTA Transplantation d'Organes - Hôpital RangueilRecruiting
  • Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital RangueilRecruiting
  • CHUVRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard mobilization strategy

protocolized early mobilization strategy

Arm Description

Outcomes

Primary Outcome Measures

Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation

Secondary Outcome Measures

The incidence of Intensive Care Unit-acquired weakness with Manual Muscle Testing (MMT) scale
The incidence and stage of pressure ulcers occurring during ICU stay with NPUAP scale
The incidence of delirium with CAM-ICU scale
Hospital stay duration
Place where the patient is transferred at the end of the hospital stay
The delay, in number of days between intubation and the first successful spontaneous breathing trial
The incidence of extubation failure defined as re-intubation within 72 hours after the first extubation
Time between intubation and the first stand-up position in days
ICU stay duration

Full Information

First Posted
July 28, 2015
Last Updated
May 4, 2017
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT02520193
Brief Title
Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
Acronym
EarlyMob
Official Title
Prospective, Randomized, Multi-center Trial to Assess the Impact of Early Mobilization on Mechanical Ventilation Duration in Intubated Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICU Acquired Weakness
Keywords
Early mobilisation, Invasive ventilation, Ventilator free days, Intensive Care Unit

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
772 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard mobilization strategy
Arm Type
No Intervention
Arm Title
protocolized early mobilization strategy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Protocolized early mobilization in ICU
Primary Outcome Measure Information:
Title
Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation
Time Frame
28 days after intubation
Secondary Outcome Measure Information:
Title
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
Title
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
Title
The incidence of delirium with CAM-ICU scale
Time Frame
end of Intensive Care Unit stay, an expected average of 10 days
Title
Hospital stay duration
Time Frame
End of hospital stay, an expected average of 20 days
Title
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
Title
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
Title
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
Title
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
Title
ICU stay duration
Time Frame
end of Intensive Care Unit stay, an expected average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent POIROUX
Phone
++33 2 41 35 64 40
Email
LaPoiroux@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lise PIQUILLOUD, MD
Phone
++41 79 556 68 27
Email
lise.piquilloud@chuv.ch
Facility Information:
Facility Name
Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Charles PREISER
Facility Name
Cliniques Universitaires Saint-Luc - Service des soins intensifs
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier WITTEBOLE
Facility Name
CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent FRAIPONT
Facility Name
CHU de Liege - Service de soins intensifs généraux
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre DAMAS
Facility Name
Cliniques Universitaires UCL de Mont-Godinne - Service intensifs généraux
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey HORLAIT
Facility Name
CHU Angers - Service de Réanimation Médicale et de Médecine Hyperbare
City
Angers
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain MERCAT
Facility Name
CHU de Brest - Service de réanimation médicale
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwenael PRAT
Facility Name
CH de Pontoise - Serive de réanimation médicale - CH René Dubos
City
Cergy Pontoise
ZIP/Postal Code
95303
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cédric CLEOPHAX
Facility Name
AP-HP Hôpital Henri Mondor - Service de Réanimation Médicale
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keyvan RAZAZI
Facility Name
CHD Vendée - Service de Réanimation Polyvalente
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle VINATIER
Facility Name
Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalente
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime LELOUP
Facility Name
CHU Grenoble - Service de Réanimation Médicale - Hôpital A, Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas TERZI
Facility Name
Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicale
City
Le Mans
ZIP/Postal Code
72037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas CHUDEAU
Facility Name
CHRU de Lille - Pôle de réanimation -Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saad NSEIR
Facility Name
CH St Joseph St Luc - Service de Réanimation Polyvalente
City
Lyon
ZIP/Postal Code
69007
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gael BOURDIN
Facility Name
Groupe Hospitalier du Havre - Service de Réanimation médico-chirurgicale - Hôpital Jacques Monod
City
Montivilliers
ZIP/Postal Code
76290
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehdi BOUSTA
Facility Name
CHU de Nantes - Service de Réanimation Médicale Polyvalente
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe GUITTON
Facility Name
CHU de Nice - Service de réanimation médicale - Hôpital de l'Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean DELLAMONICA
Facility Name
AP-HP Hôpital Tenon - Service de Réanimation
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muriel FARTOUKH
First Name & Middle Initial & Last Name & Degree
Tai PHAM
Facility Name
AP-HP Hôpitaux Universitaires Paris Ouest- Service de réanimation médicale - Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Luc DIEHL
Facility Name
CHU Toulouse - service de néphrologie Hémodialyse HTA Transplantation d'Organes - Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier COINTAULT
Facility Name
Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie RUIZ
Facility Name
CHUV
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Piquilloud Imboden
Email
lise.piquilloud@chuv.ch

12. IPD Sharing Statement

Learn more about this trial

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

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