Status:
COMPLETED
Does Deflating the Tracheal Cuff Shorten Weaning Time?
Lead Sponsor:
Hospital Virgen de la Salud
Conditions:
Weaning
Tracheostomy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether deflating the tracheal cuff in tracheostomized patients, during disconnections from ventilatory support along the weaning phase shortens the weaning t...
Detailed Description
Randomized controlled trial. Study protocol: patients will be eligible for the study after fulfilling standard criteria for weaning initiation and stratified for risk of aspiration (drink test)into t...
Eligibility Criteria
Inclusion
- Inclusion criteria: tracheostomized patients for any of the following reasons:
- Prolonged time under mechanical ventilation (\>21 days) or prolonged weaning.
- Motor component of Glasgow Coma Score \<6 points or inability to adequate manage the airway (\>2 aspirations every 8 hours).
- Exclusion Criteria:
- High risk of aspiration (neuromuscular disease affecting bulbar functions, tracheostomies indicated as a part of a surgical procedure involving the upper airway or high risk of aspiration observed after specific evaluation previous to randomization).
- Death before starting weaning attempts.
Exclusion
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00956540
Start Date
December 1 2009
End Date
May 1 2011
Last Update
September 27 2011
Active Locations (1)
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1
Hospital Virgen de la Salud
Toledo, Toledo, Spain, 45004