NCT01143103

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

September 24, 2012

Status Verified

June 1, 2010

Enrollment Period

2 years

First QC Date

June 2, 2010

Last Update Submit

September 21, 2012

Conditions

Neurologic Disorder

Keywords

Respiratory therapy in neurologic disorder

Outcome Measures

Primary Outcomes (2)

  • Duration of stay in intensive care unit

  • Number of additional unplanned respiratory therapy treatment

Secondary Outcomes (5)

  • 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

Study Arms (2)

Respiratory therapy with cough assist

EXPERIMENTAL
Device: Cough assist (Philips,respironics)

Usual respiratory therapy

ACTIVE COMPARATOR
Other: Usual respiratory therapy

Interventions

Cough assist (Philips,respironics)DEVICE
Respiratory therapy with cough assist
Usual respiratory therapyOTHER
Usual respiratory therapy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Death expected in the following 24h
  • Bulbar dysfunction if extubated
  • pneumothorax
  • intracerebral mass effect
  • elevated intracranial pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Geneva

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

  • Didier Tassaux

    University Hospital, Geneva

    STUDY DIRECTOR

  • Lise Piquilloud

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 14, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

September 24, 2012

Record last verified: 2010-06

Locations

CH(1)