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

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

Tracking Information

• First Submitted Date: December 19, 2013
• First Posted Date: December 27, 2013
• Last Update Posted Date: May 24, 2019
• Actual Study Start Date: December 13, 2013
• Actual Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 19, 2013): Weaning from mechanical ventilation, mortality [ Time Frame: day 28 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Early Chair Sitting Exercise in Mechanically Ventilated Critically Ill Patients
• 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.

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours

Intervention

Procedure: Early chair sitting exercise

A chair sitting exercise will be done at least once a day and for > 1 hour

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: February 7, 2019): 38
• Original Estimated Enrollment (submitted: December 19, 2013): 40
• Actual Study Completion Date: December 31, 2016
• Actual Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02021227
• Other Study ID Numbers: 9231
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Montpellier
• Study Sponsor: University Hospital, Montpellier
• Collaborators: Not Provided

Investigators

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

• PRS Account: University Hospital, Montpellier
• Verification Date: May 2019