Early Chair Sitting Exercise in Mechanically Ventilated Critically Ill Patients

Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours Clinical Trial

— RehabVent  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02021227
• Other study ID #: 9231
• Status: Terminated
• Phase: N/A
• Start date: December 13, 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Respiratory Failure With Acute Decompensation Requiring Mechanical Ventilation for More Than 48 Hours
• Critical Illness
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Lapeyronie University Hospital, Intensive Care Department	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weaning from mechanical ventilation, mortality		day 28
Secondary	ICU length of stay		day 28
Secondary	Extubation success	success or failure	day 28
Secondary	Nosocomial infections		day 28