- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00548483
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Chao-Hsien Lee, MD
- Phone Number: +886-2-23926589
- Email: L49428@ms2.mmh.org.tw
Study Locations
-
-
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Taipei, Taiwan, 104
- Recruiting
- No. 92, SEC. 2, CHUNG SHAN N. RD, TAIPEI, TAIWAN.
-
Contact:
- Chao-Hsien Lee, MD
- Phone Number: 886-2-23926589
- Email: L49428@ms2.mmh.org.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All patients were > 18 years of age and met the following weaning criteria:
- Temperature ≤ 38°C for > 8 hours,
- Discontinuous use of sedatives,
- Heart rate ≥ 70 and ≤ 130 /min,
- Systolic blood pressure (SBP) ≥ 80 mm Hg in the absence of vasopressors,
- Fraction of inspired oxygen (FiO2) ≤ 0.6, PaO2 ≥ 60, and partial pressure of oxygen (PaO2)/FiO2 ratio > 200,
- Positive end-expiratory pressure (PEEP) ≤ 5 cm H2O,
- Rapid and shallow ratio of frequency to tidal volume (f/VT ≤ 105),
- Minute ventilation ≤ 15 L/min, and
- pH ≥ 7.3. Supplemental oxygen was continued to maintain an oxygen saturation > 95% as measured by a pulse oximeter.
Exclusion Criteria:
- A history of extubation during the same hospitalization
- Administration of corticosteroids seven days prior to extubation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
dexamethasone 5mg was administered every 6 hour for 1 day
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume)
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chao-Hsien Lee, MD, Mackay Memorial Hospital
Publications and helpful links
General Publications
- Francois B, Bellissant E, Gissot V, Desachy A, Normand S, Boulain T, Brenet O, Preux PM, Vignon P; Association des Reanimateurs 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. doi: 10.1016/S0140-6736(07)60526-1.
- 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. doi: 10.1186/cc5957.
- 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. doi: 10.1097/01.CCM.0000214678.92134.BD. Erratum In: Crit Care Med. 2007 May;35(5):1454.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Endotracheal intubation
- Corticosteroids
- Laryngeal edema
- Cuff-leak test
- 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
- Respiratory Tract Diseases
- Respiration Disorders
- Respiratory Insufficiency
- Airway Obstruction
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- MMH-I-S-107
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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