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

Mackay Memorial Hospital

Status and phase: Unknown; Phase 2

Conditions: Airway Obstruction

Treatments: Drug: dexamethasone (Oradexon, Nederland)

Study type: Interventional

Funder types: Other

Identifiers

NCT00548483

MMH-I-S-107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

1

Active Comparator group

Description:

dexamethasone 5mg was administered every 6 hour for 1 day

Treatment:

Drug: dexamethasone (Oradexon, Nederland)

2

Active Comparator group

Description:

dexamethasone 10mg was administered every 6 hour for 1 day

Treatment:

Drug: dexamethasone (Oradexon, Nederland)