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

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ClinicalTrials.gov Identifier: NCT01143103
Recruitment Status : Withdrawn
First Posted : June 14, 2010
Last Update Posted : September 24, 2012
Sponsor:
Information provided by:
University Hospital, Geneva

Brief 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.

Condition or disease Intervention/treatment Phase
Neurologic Disorder Device: Cough assist (Philips,respironics) Other: Usual respiratory therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : July 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Respiratory therapy with cough assist Device: Cough assist (Philips,respironics)
Active Comparator: Usual respiratory therapy Other: Usual respiratory therapy



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

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


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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

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

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 Posted: June 14, 2010    Key Record Dates
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