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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01143103
First Posted: June 14, 2010
Last Update Posted: September 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Geneva
  Purpose
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.

Condition Intervention
Neurologic Disorder Device: Cough assist (Philips,respironics) Other: Usual respiratory therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison Between Respiratory Physiotherapy With Cough Assist Technique and Usual Respiratory Care in Intensive Care Patients Suffering of Neurologic Disorder

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Duration of stay in intensive care unit
  • Number of additional unplanned respiratory therapy treatment

Secondary Outcome Measures:
  • Duration of stay in the hospital
  • Pulmonary infection
  • Oxygenation parameters before and after respiratory therapy
  • Intracranial pressure elevation during respiratory therapy if an intracerebral pressure monitoring is available
  • Need of reintubation in the 48h following successful intubation

Enrollment: 0
Study Start Date: July 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Respiratory therapy with cough assist Device: Cough assist (Philips,respironics)
Active Comparator: Usual respiratory therapy Other: Usual respiratory therapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143103


Locations
Switzerland
University hospital of Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Study Director: Didier Tassaux University Hospital, Geneva
Principal Investigator: Lise Piquilloud University Hospital, Geneva
  More Information

Responsible Party: Didier Tassaux, MD, Intensive care unit, university hospital of Geneva
ClinicalTrials.gov Identifier: NCT01143103     History of Changes
Other Study ID Numbers: cough assist
cough assist ( Other Identifier: University hospital of Geneva )
First Submitted: June 2, 2010
First Posted: June 14, 2010
Last Update Posted: September 24, 2012
Last Verified: June 2010

Keywords provided by University Hospital, Geneva:
Respiratory therapy in neurologic disorder

Additional relevant MeSH terms:
Disease
Nervous System Diseases
Pathologic Processes