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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours Procedure: Early chair sitting exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : December 13, 2013
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

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


Outcome Measures
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Primary Outcome Measures :
  1. Weaning from mechanical ventilation, mortality [ Time Frame: day 28 ]

Secondary Outcome Measures :
  1. ICU length of stay [ Time Frame: day 28 ]
  2. Extubation success [ Time Frame: day 28 ]
    success or failure

  3. Nosocomial infections [ Time Frame: day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02021227


Locations
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France
Lapeyronie University Hospital, Intensive Care Department
Montpellier, France, 34170
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Kada KLOUCHE, MD PhD Hopital de Montpellier
More Information
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Publications of Results:

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02021227    
Other Study ID Numbers: 9231
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Keywords provided by University Hospital, Montpellier:
Acute respiratory failure
Mechanical ventilation
Rehabilitation
 Exercise chair sitting
Weaning
Chronic respiratory failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases