Comparison Between Respiratory Therapy With Cough Assist Technique and Usual Respiratory Therapy in Intensive Care Patients Suffering of Neurologic Disorder

Neurologic Disorder Clinical Trial

Official title:

Comparison Between Respiratory Physiotherapy With Cough Assist Technique and Usual Respiratory Care in Intensive Care Patients Suffering of Neurologic Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01143103
• Other study ID #: cough assist
• Secondary ID: cough assist
• Status: Withdrawn
• Phase: N/A
• First received: June 2, 2010
• Last updated: September 21, 2012
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2010
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The present study aims to compare the efficiency of respiratory therapy with cough assist and the efficiency of usual respiratory therapy in intensive care patients suffering of neurologic disorder and cough ineffectiveness. The investigators hypothesis is that cough assist is more efficient than usual respiratory care in this group of patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Peak flow < 270 ml if the patient has one of the following diagnostic: post neurosurgery status, cerebral trauma, tetraparesia or tetraplegia

Exclusion Criteria:

• Death expected in the following 24h

• Bulbar dysfunction if extubated

• pneumothorax

• intracerebral mass effect

• elevated intracranial pressure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurologic Disorder

Intervention

Device:
• Cough assist (Philips,respironics)

Other:
• Usual respiratory therapy

Locations

Country	Name	City	State
Switzerland	University hospital of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of stay in intensive care unit			No
Primary	Number of additional unplanned respiratory therapy treatment			No
Secondary	Duration of stay in the hospital			No
Secondary	Pulmonary infection			No
Secondary	Oxygenation parameters before and after respiratory therapy			No
Secondary	Intracranial pressure elevation during respiratory therapy if an intracerebral pressure monitoring is available			Yes
Secondary	Need of reintubation in the 48h following successful intubation			No