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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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00548483
Enrollment
80
Registered
2007-10-24
Start date
2007-04-30
Completion date
2008-05-31
Last updated
2008-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Obstruction

Keywords

Endotracheal intubation, Laryngeal edema, Cuff-leak test, Corticosteroids, This study was to ascertain whether administration of dexamethasone to critically intubated patients prevent postextubation airway obstruction., This study was to compare high dose and low dose dexamethasone in preventing noninvasive ventilation or reintubation among critically ill intubated patients

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.

Interventions

DRUGdexamethasone (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

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

Taiwan

Contacts

Primary ContactChao-Hsien Lee, MD
L49428@ms2.mmh.org.tw+886-2-23926589

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026