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

ICU Acquired Weakness Clinical Trial

— EarlyMob  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02520193
• Other study ID #: PHRIP 2014-01
• Secondary ID: 2015-A00741-48
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2015
• Last updated: May 4, 2017
• Start date: December 2015
• Est. completion date: August 2018

Study information

• Verified date: July 2016
• Source: University Hospital, Angers
• Contact: Laurent POIROUX
• Phone: ++33 2 41 35 64 40
• Email: LaPoiroux[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 772
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• ICU Acquired Weakness

Intervention

Procedure:
• Protocolized early mobilization in ICU

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc - Service des soins intensifs	Bruxelles
Belgium	Hôpital Erasme	Bruxelles
Belgium	CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques	Liege
Belgium	CHU de Liege - Service de soins intensifs généraux	Liege
Belgium	Cliniques Universitaires UCL de Mont-Godinne - Service intensifs généraux	Yvoir
France	CHU Angers - Service de Réanimation Médicale et de Médecine Hyperbare	Angers
France	CHU de Brest - Service de réanimation médicale	Brest
France	CH de Pontoise - Serive de réanimation médicale - CH René Dubos	Cergy Pontoise
France	AP-HP Hôpital Henri Mondor - Service de Réanimation Médicale	Creteil
France	CHD Vendée - Service de Réanimation Polyvalente	La Roche Sur Yon
France	Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalente	La Rochelle
France	CHU Grenoble - Service de Réanimation Médicale - Hôpital A, Michallon	La Tronche
France	Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicale	Le Mans
France	CHRU de Lille - Pôle de réanimation -Hôpital Roger Salengro	Lille
France	CH St Joseph St Luc - Service de Réanimation Polyvalente	Lyon
France	Groupe Hospitalier du Havre - Service de Réanimation médico-chirurgicale - Hôpital Jacques Monod	Montivilliers
France	CHU de Nantes - Service de Réanimation Médicale Polyvalente	Nantes
France	CHU de Nice - Service de réanimation médicale - Hôpital de l'Archet	Nice
France	AP-HP Hôpital Tenon - Service de Réanimation	Paris
France	AP-HP Hôpitaux Universitaires Paris Ouest- Service de réanimation médicale - Hôpital Européen Georges Pompidou	Paris
France	CHU Toulouse - service de néphrologie Hémodialyse HTA Transplantation d'Organes - Hôpital Rangueil	Toulouse
France	Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital Rangueil	Toulouse
Switzerland	CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Countries where clinical trial is conducted

Belgium,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days without mechanical ventilation (ventilator-free days) during the 28 days after intubation		28 days after intubation
Secondary	The incidence of Intensive Care Unit-acquired weakness with Manual Muscle Testing (MMT) scale		end of Intensive Care Unit stay, an expected average of 10 days
Secondary	The incidence and stage of pressure ulcers occurring during ICU stay with NPUAP scale		end of Intensive Care Unit stay, an expected average of 10 days
Secondary	The incidence of delirium with CAM-ICU scale		end of Intensive Care Unit stay, an expected average of 10 days
Secondary	Hospital stay duration		End of hospital stay, an expected average of 20 days
Secondary	Place where the patient is transferred at the end of the hospital stay		End of hospital stay, an expected average of 20 days
Secondary	The delay, in number of days between intubation and the first successful spontaneous breathing trial		End of Intensive Care Unit stay, an expected average of 10 days
Secondary	The incidence of extubation failure defined as re-intubation within 72 hours after the first extubation		end of Intensive Care Unit stay, an expected average of 10 days
Secondary	Time between intubation and the first stand-up position in days		end of Intensive Care Unit stay, an expected average of 10 days
Secondary	ICU stay duration		end of Intensive Care Unit stay, an expected average of 10 days