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

• Sponsor: Mackay Memorial Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00548483
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Airway Obstruction	Drug: dexamethasone (Oradexon, Nederland)	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: Phase 2 Study of Comparison of High Dose and Low Dose Dexamethasone in Preventing Post-Extubation Airway Obstruction in Adults
• Study Start Date: Apr 1, 2007
• Anticipated Primary Completion Date: Mar 1, 2008
• Anticipated Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 dexamethasone 5mg was administered every 6 hour for 1 day	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: 2 dexamethasone 10mg was administered every 6 hour for 1 day	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

Outcome Measures

Primary Outcome Measures

1. absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume) [48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	No. 92, SEC. 2, CHUNG SHAN N. RD, TAIPEI, TAIWAN.	Taipei		Taiwan	104

Sponsors and Collaborators

• Mackay Memorial Hospital

Investigators

• Principal Investigator: Chao-Hsien Lee, MD, Mackay Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00548483
• Other Study ID Numbers: MMH-I-S-107
• First Posted: Oct 24, 2007
• Last Update Posted: May 28, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: 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
• Additional relevant MeSH terms: Airway Obstruction; Dexamethasone

Study Results

No Results Posted as of May 28, 2008