Early Chair Sitting Exercise in Mechanically Ventilated Critically Ill Patients

Not Applicable

Terminated

• Conditions: Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours
• Interventions: Procedure: Early chair sitting exercise

• Registration Number: NCT02021227
• Lead Sponsor: University Hospital, Montpellier

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 available

Study Timeline

• Study Start: 2013-12-13
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chair sitting group	Early chair sitting exercise	-

Primary Outcome Measures

Name	Time	Method
Weaning from mechanical ventilation, mortality	day 28

Secondary Outcome Measures

Name	Time	Method
Extubation success	day 28	success or failure
ICU length of stay	day 28
Nosocomial infections	day 28

Trial Locations

Locations (1)

Lapeyronie University Hospital, Intensive Care Department; 🇫🇷 Montpellier, France