Clinical trial NCT02021227: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Weaning from mechanical ventilation, mortality
timeFrame: day 28
Secondary outcomes:
measure: ICU length of stay
timeFrame: day 28
measure: Extubation success
timeFrame: day 28
measure: Nosocomial infections
timeFrame: day 28
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Lapeyronie University Hospital, Intensive Care Department
Study officials:
affiliation: Hopital de Montpellier
name: Kada KLOUCHE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.