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

Airway Obstruction Clinical Trial

Official title:

Phase 2 Study of Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00548483
• Other study ID #: MMH-I-S-107
• Status: Recruiting
• Phase: Phase 2
• First received: October 23, 2007
• Last updated: May 27, 2008
• Start date: April 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Mackay Memorial Hospital
• Contact: Chao-Hsien Lee, MD
• Phone: +886-2-23926589
• Email: L49428[@]ms2.mmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

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

Locations

Country	Name	City	State
Taiwan	No. 92, SEC. 2, CHUNG SHAN N. RD, TAIPEI, TAIWAN.	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Cheng KC, Hou CC, Huang HC, Lin SC, Zhang H. Intravenous injection of methylprednisolone reduces the incidence of postextubation stridor in intensive care unit patients. Crit Care Med. 2006 May;34(5):1345-50. Erratum in: Crit Care Med. 2007 May;35(5):1454. — View Citation

François B, Bellissant E, Gissot V, Desachy A, Normand S, Boulain T, Brenet O, Preux PM, Vignon P; Association des Réanimateurs du Centre-Ouest (ARCO). 12-h pretreatment with methylprednisolone versus placebo for prevention of postextubation laryngeal oedema: a randomised double-blind trial. Lancet. 2007 Mar 31;369(9567):1083-9. — View Citation

Lee CH, Peng MJ, Wu CL. Dexamethasone to prevent postextubation airway obstruction in adults: a prospective, randomized, double-blind, placebo-controlled study. Crit Care. 2007;11(4):R72. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume)		48 hours	No