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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Mackay Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00548483
First received: October 23, 2007
Last updated: May 27, 2008
Last verified: May 2008

October 23, 2007
May 27, 2008
April 2007
March 2008   (final data collection date for primary outcome measure)
absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00548483 on ClinicalTrials.gov Archive Site
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Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults
Phase 2 Study of Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Airway Obstruction
Drug: dexamethasone (Oradexon, Nederland)
dexamethasone 5mg was administered every 6 hour for 1 day in group 1 and dexamethasone 10mg was administered every 6 hour for 1 day in group 2
  • Active Comparator: 1
    dexamethasone 5mg was administered every 6 hour for 1 day
    Intervention: Drug: dexamethasone (Oradexon, Nederland)
  • Active Comparator: 2
    dexamethasone 10mg was administered every 6 hour for 1 day
    Intervention: Drug: dexamethasone (Oradexon, Nederland)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
May 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 95 Years
No
Contact: Chao-Hsien Lee, MD +886-2-23926589 L49428@ms2.mmh.org.tw
Taiwan
 
NCT00548483
MMH-I-S-107
Yes
Chao-Hsien, Lee, Mackay memorial hospital
Mackay Memorial Hospital
Not Provided
Principal Investigator: Chao-Hsien Lee, MD Mackay Memorial Hospital
Mackay Memorial Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP