Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults

• Status: Unknown status
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The specific objectives were to determine whether high dose dexamethasone are more effective than low dose dexamethasone in the reduction or prevention of post-extubation airway obstruction among patients with a cuff leak volume (CLV) < 110 mL.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mackay Memorial Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

All patients were > 18 years of age and met the following weaning criteria:

1. Temperature ≤ 38°C for > 8 hours,

2. Discontinuous use of sedatives,

3. Heart rate ≥ 70 and ≤ 130 /min,

4. Systolic blood pressure (SBP) ≥ 80 mm Hg in the absence of vasopressors,

5. Fraction of inspired oxygen (FiO2) ≤ 0.6, PaO2 ≥ 60, and partial pressure of oxygen (PaO2)/FiO2 ratio > 200,

6. Positive end-expiratory pressure (PEEP) ≤ 5 cm H2O,

7. Rapid and shallow ratio of frequency to tidal volume (f/VT ≤ 105),

8. Minute ventilation ≤ 15 L/min, and

9. pH ≥ 7.3. Supplemental oxygen was continued to maintain an oxygen saturation > 95% as measured by a pulse oximeter.

Exclusion Criteria:

1. A history of extubation during the same hospitalization

2. Administration of corticosteroids seven days prior to extubation.