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

Primary Purpose

Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early chair sitting exercise
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours focused on measuring Acute respiratory failure, Mechanical ventilation, Rehabilitation, Exercise chair sitting, Weaning, Chronic respiratory failure

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lapeyronie University Hospital, Intensive Care Department

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Standard group

Chair sitting group

Arm Description

Outcomes

Primary Outcome Measures

Weaning from mechanical ventilation, mortality

Secondary Outcome Measures

ICU length of stay
Extubation success
success or failure
Nosocomial infections

Full Information

First Posted
December 19, 2013
Last Updated
May 23, 2019
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02021227
Brief Title
Early Chair Sitting Exercise in Mechanically Ventilated Critically Ill Patients
Acronym
RehabVent
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
sufficient enrollment
Study Start Date
December 13, 2013 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours
Keywords
Acute respiratory failure, Mechanical ventilation, Rehabilitation, Exercise chair sitting, Weaning, Chronic respiratory failure

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Standard group
Arm Type
No Intervention
Arm Title
Chair sitting group
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Early chair sitting exercise
Intervention Description
A chair sitting exercise will be done at least once a day and for > 1 hour
Primary Outcome Measure Information:
Title
Weaning from mechanical ventilation, mortality
Time Frame
day 28
Secondary Outcome Measure Information:
Title
ICU length of stay
Time Frame
day 28
Title
Extubation success
Description
success or failure
Time Frame
day 28
Title
Nosocomial infections
Time Frame
day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kada KLOUCHE, MD PhD
Organizational Affiliation
Hopital de Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lapeyronie University Hospital, Intensive Care Department
City
Montpellier
ZIP/Postal Code
34170
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15264418
Citation
Canaud B, Formet C, Raynal N, Amigues L, Klouche K, Leray-Moragues H, Beraud JJ. Vascular access for extracorporeal renal replacement therapy in the intensive care unit. Contrib Nephrol. 2004;144:291-307. doi: 10.1159/000078897. No abstract available.
Results Reference
result

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Early Chair Sitting Exercise in Mechanically Ventilated Critically Ill Patients

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