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
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
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
NCT ID
NCT02021227
First Posted
December 19, 2013
Last Updated
May 23, 2019
Sponsor
University Hospital, Montpellier
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
Learn more about this trial
Early Chair Sitting Exercise in Mechanically Ventilated Critically Ill Patients
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