Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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

June 2, 2010
September 21, 2012
July 2010
July 2012   (final data collection date for primary outcome measure)
  • Duration of stay in intensive care unit [ Designated as safety issue: No ]
  • Number of additional unplanned respiratory therapy treatment [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01143103 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison Between Respiratory Therapy With Cough Assist Technique and Usual Respiratory Therapy in Intensive Care Patients Suffering of Neurologic Disorder
Comparison Between Respiratory Physiotherapy With Cough Assist Technique and Usual Respiratory Care in Intensive Care Patients Suffering of Neurologic Disorder

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Neurologic Disorder
  • Device: Cough assist (Philips,respironics)
  • Other: Usual respiratory therapy
  • Experimental: Respiratory therapy with cough assist
    Intervention: Device: Cough assist (Philips,respironics)
  • Active Comparator: Usual respiratory therapy
    Intervention: Other: Usual respiratory therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01143103
cough assist, cough assist
No
Didier Tassaux, MD, Intensive care unit, university hospital of Geneva
University Hospital, Geneva
Not Provided
Study Director: Didier Tassaux University Hospital, Geneva
Principal Investigator: Lise Piquilloud University Hospital, Geneva
University Hospital, Geneva
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP