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

NCT02520193 | Unknown

• 2 other identifiers: PHRIP 2014-012015-A00741-48
• Study Type: interventional
• Target: 772
• Locations: 3 countries
• Sites: 23

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.

Conditions

ICU Acquired Weakness

Keywords

Early mobilisation; Invasive ventilation; Ventilator free days; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

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

  28 days after intubation

Secondary Outcomes (9)

• 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

• 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

• The incidence of delirium with CAM-ICU scale

  end of Intensive Care Unit stay, an expected average of 10 days

• Hospital stay duration

  End of hospital stay, an expected average of 20 days

• Place where the patient is transferred at the end of the hospital stay

  End of hospital stay, an expected average of 20 days

Study Arms (2)

Standard mobilization strategy

NO INTERVENTION

protocolized early mobilization strategy

EXPERIMENTAL

Procedure: Protocolized early mobilization in ICU

Interventions

Protocolized early mobilization in ICU PROCEDURE

protocolized early mobilization strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission in intensive care unit
• Invasive ventilation for more than 24 hours
• Invasive ventilation for less than 48 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (23)

Hôpital Erasme

Brussels, 1070, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc - Service des soins intensifs

Brussels, 1200, Belgium

RECRUITING

CHR Citadelle - Services Soins intensifs, gériatriques et pédiatriques

Liège, 4000, Belgium

RECRUITING

CHU de Liege - Service de soins intensifs généraux

Liège, 4000, Belgium

RECRUITING

Cliniques Universitaires UCL de Mont-Godinne - Service intensifs généraux

Yvoir, 5530, Belgium

RECRUITING

CHU Angers - Service de Réanimation Médicale et de Médecine Hyperbare

Angers, 49100, France

RECRUITING

CHU de Brest - Service de réanimation médicale

Brest, 29609, France

RECRUITING

CH de Pontoise - Serive de réanimation médicale - CH René Dubos

Cergy-Pontoise, 95303, France

RECRUITING

AP-HP Hôpital Henri Mondor - Service de Réanimation Médicale

Créteil, 94010, France

RECRUITING

CHD Vendée - Service de Réanimation Polyvalente

La Roche-sur-Yon, 85925, France

RECRUITING

Centre Hospitalier La Rochelle - Ré- Aunis - Réanimation polyvalente

La Rochelle, 17000, France

RECRUITING

CHU Grenoble - Service de Réanimation Médicale - Hôpital A, Michallon

La Tronche, 38700, France

RECRUITING

Centre Hospitalier Le Mans - Service de Réanimation médico-chirurgicale

Le Mans, 72037, France

RECRUITING

CHRU de Lille - Pôle de réanimation -Hôpital Roger Salengro

Lille, 59037, France

RECRUITING

CH St Joseph St Luc - Service de Réanimation Polyvalente

Lyon, 69007, France

RECRUITING

Groupe Hospitalier du Havre - Service de Réanimation médico-chirurgicale - Hôpital Jacques Monod

Montivilliers, 76290, France

RECRUITING

CHU de Nantes - Service de Réanimation Médicale Polyvalente

Nantes, 44093, France

RECRUITING

CHU de Nice - Service de réanimation médicale - Hôpital de l'Archet

Nice, 06202, France

RECRUITING

AP-HP Hôpital Tenon - Service de Réanimation

Paris, 75020, France

RECRUITING

AP-HP Hôpitaux Universitaires Paris Ouest- Service de réanimation médicale - Hôpital Européen Georges Pompidou

Paris, 75908, France

RECRUITING

CHU Toulouse - service de néphrologie Hémodialyse HTA Transplantation d'Organes - Hôpital Rangueil

Toulouse, 31059, France

RECRUITING

Service de Réanimation Polyvalente -CHU de Toulouse - Hôpital Rangueil

Toulouse, 31059, France

RECRUITING

CHUV

Lausanne, CH-1011, Switzerland

RECRUITING

MeSH Terms

Interventions

Intensive Care Units

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Central Study Contacts

Laurent POIROUX

CONTACT

++33 2 41 35 64 40; LaPoiroux@chu-angers.fr

Lise PIQUILLOUD, MD

CONTACT

++41 79 556 68 27; lise.piquilloud@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 11, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: August 1, 2018
• Last Updated: May 5, 2017

Record last verified: 2016-07

Locations

FR (17); BE (5); CH (1)