Phase 4
Completed N=195
Does Deflating the Tracheal Cuff Shorten Weaning Time?
Weaning · Tracheostomy
Source: ClinicalTrials.gov NCT00956540 ↗
Enrolled (actual)
195
Serious AEs
25.6%
Results posted
Sep 2011
Primary outcomePrimary: Weaning Time — 4.95; 10.15; 4.95; 10.15 day
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 time.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weaning Time |
4.95; 10.15; 4.95; 10.15 | — |
| SECONDARY Tracheobronchitis and Pneumonia |
— | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT00956540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.