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

Phase 2

• Conditions: Airway Obstruction
• Interventions: Drug: dexamethasone (Oradexon, Nederland)

• Registration Number: NCT00548483
• Lead Sponsor: Mackay Memorial Hospital

Brief 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.

Detailed Description

Controversy currently exists regarding the effectiveness of prophylactic steroid therapy for patients considered at high risk for post-extubation stridor. Studies regarding the efficacy of prophylactic corticosteroids for intubated patients have yielded conflicting results due to differences in the number, dose, or type of corticosteroids administered.

Only a limited number of prospective trials involving adults and evaluating the benefits and the dose of corticosteroid therapy prior to extubation have been conducted.The present study was conducted to evaluate the effects of prophylactic dexamethasone therapy for a subset of high-risk patients who had been intubated for \> 48 hours and who were undergoing their first elective extubation in an ICU setting.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-10-23
• Study First Submitted QC: 2007-10-23
• Study First Posted: 2007-10-24
• Primary Completion: 2008-03
• Status Verified: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2008-05-27
• Last Update Posted: 2008-05-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	dexamethasone (Oradexon, Nederland)	dexamethasone 5mg was administered every 6 hour for 1 day
2	dexamethasone (Oradexon, Nederland)	dexamethasone 10mg was administered every 6 hour for 1 day

Primary Outcome Measures

Name	Time	Method
absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume)	48 hours

Trial Locations

Locations (1)

No. 92, SEC. 2, CHUNG SHAN N. RD, TAIPEI, TAIWAN.; 🇨🇳 Taipei, Taiwan