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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This study has been withdrawn prior to enrollment.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:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01143103
First received: June 2, 2010
Last updated: September 21, 2012
Last verified: June 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Duration of stay in intensive care unit [ Designated as safety issue: No ]
  • Number of additional unplanned respiratory therapy treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of stay in the hospital [ Designated as safety issue: No ]
  • Pulmonary infection [ Designated as safety issue: No ]
  • Oxygenation parameters before and after respiratory therapy [ Designated as safety issue: No ]
  • Intracranial pressure elevation during respiratory therapy if an intracerebral pressure monitoring is available [ Designated as safety issue: Yes ]
  • Need of reintubation in the 48h following successful intubation [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 2, 2010
Last Updated: September 21, 2012
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Nervous System Diseases
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 21, 2013