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

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ClinicalTrials.gov Identifier: NCT02021227
Recruitment Status : Terminated (sufficient enrollment)
First Posted : December 27, 2013
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE December 19, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date May 24, 2019
Actual Study Start Date  ICMJE December 13, 2013
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
Weaning from mechanical ventilation, mortality [ Time Frame: day 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • ICU length of stay [ Time Frame: day 28 ]
  • Extubation success [ Time Frame: day 28 ]
    success or failure
  • Nosocomial infections [ Time Frame: day 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
  • ICU length of stay [ Time Frame: day 28 ]
  • Extubation success [ Time Frame: day 28 ]
  • Nosocomial infections [ Time Frame: day 28 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Chair Sitting Exercise in Mechanically Ventilated Critically Ill Patients
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours
Intervention  ICMJE Procedure: Early chair sitting exercise
A chair sitting exercise will be done at least once a day and for > 1 hour
Study Arms  ICMJE
  • No Intervention: Standard group
  • Chair sitting group
    Intervention: Procedure: Early chair sitting exercise
Publications * Canaud B, Formet C, Raynal N, Amigues L, Klouche K, Leray-Moragues H, Béraud JJ. Vascular access for extracorporeal renal replacement therapy in the intensive care unit. Contrib Nephrol. 2004;144:291-307. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 7, 2019)
38
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2013)
40
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02021227
Other Study ID Numbers  ICMJE 9231
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kada KLOUCHE, MD PhD Hopital de Montpellier
PRS Account University Hospital, Montpellier
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP