Early Chair Sitting Exercise in Mechanically Ventilated Critically Ill Patients (RehabVent)

May 23, 2019 updated by: University Hospital, Montpellier

Effects of Chair Sitting Exercise Intervention on Weaning From Mechanical Ventilation and Mortality of Critically Ill Patients With Acute Respiratory Failure: a Randomised Controlled Trial.

The occurrence of an acute respiratory failure necessitates mostly admission to ICU and mechanical ventilation (MV). Rapid and safe discontinuation of MV should be the objective for the majority of patients. Many reasons may contribute to weaning, extubation failure and prolongation of MV. Critical illness myopathy, induced by immobilisation and prolonged MV, may represent a main factor and early rehabilitation may reverse these conditions and improve the success of weaning from MV.The objective of this study is to evaluate the effect of an early chair sitting (while the patient is awake but still mechanically ventilated) on weaning from mechanical ventilation and ICU mortality.

Methods: Chronic respiratory failure patients with an acute decompensation and requiring MV for more than 48 hours will be randomized to 2 groups at the initiation of weaning schedule: the studied group (20 patients): chair-sitting group will be transferred from bed to arm chair for at least 1 hour and once a day; the control group will stay in bed until extubation. Ventilator free days, extubation failure, nosocomial infections, ICU mortality, ICU length of stay are assessed and compared between groups. Expected results: Early chair sitting would decrease MV duration, number of extubation failure, nosocomial infections and ICU mortality. Feasibility and safety of this intervention will also be evaluated and also the related work load.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • 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 Locations

  • France
      • Montpellier, France, 34170
        • Lapeyronie University Hospital, Intensive Care Department

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

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute respiratory failure
  • Requiring mechanical ventilation for more than 48 h
  • Informed consent

Exclusion Criteria:

  • Body mass index > 40 kg/m2
  • Severe neuropathy
  • Hemodynamic instability, acute cor pulmonary embolism, acute myocardial ischemia/necrosis, hypoxemia
  • Deep sedation

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
Intervention / Treatment
No Intervention: Standard group
Other: Chair sitting group
Procedure: Early chair sitting exercise
A chair sitting exercise will be done at least once a day and for > 1 hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weaning from mechanical ventilation, mortality
Time Frame: day 28
day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU length of stay
Time Frame: day 28
day 28
Extubation success
Time Frame: day 28
success or failure
day 28
Nosocomial infections
Time Frame: day 28
day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Kada KLOUCHE, MD PhD, Hopital de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 13, 2013

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 27, 2013

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9231 (CTEP)

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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