Impact of Early Mobilization on Mechanical Ventilation Du... | NCT02520193

ID	Type	Description	Link
2015-A00741-48	Other Identifier	ANSM

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Aug 2018Estimated

First Submitted Date

Jul 28, 2015

First Submission Date that Met QC Criteria

Aug 10, 2015

First Posted Date

Aug 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2017

Last Update Posted Date

May 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

772Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard mobilization strategy	No Intervention
protocolized early mobilization strategy	Experimental		Procedure: Protocolized early mobilization in ICU

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Protocolized early mobilization in ICU	Procedure		protocolized early mobilization strategy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Erasme	Recruiting	Brussels		1070	Belgium

ID	Term
D006757	Hospital Units
D006268	Health Facilities
D005159	Health Care Facilities Workforce and Services