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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Mackay Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00548483
First received: October 23, 2007
Last updated: May 27, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Airway Obstruction
Drug: dexamethasone (Oradexon, Nederland)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: April 2007
Estimated Study Completion Date: May 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548483

Contacts
Contact: Chao-Hsien Lee, MD +886-2-23926589 L49428@ms2.mmh.org.tw

Locations
Taiwan
No. 92, SEC. 2, CHUNG SHAN N. RD, TAIPEI, TAIWAN. Recruiting
Taipei, Taiwan, 104
Contact: Chao-Hsien Lee, MD    886-2-23926589    L49428@ms2.mmh.org.tw   
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: Chao-Hsien Lee, MD Mackay Memorial Hospital
  More Information

Publications:
Responsible Party: Chao-Hsien, Lee, Mackay memorial hospital
ClinicalTrials.gov Identifier: NCT00548483     History of Changes
Other Study ID Numbers: MMH-I-S-107
Study First Received: October 23, 2007
Last Updated: May 27, 2008
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Mackay Memorial Hospital:
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
Respiration Disorders
Respiratory Insufficiency
Respiratory Tract Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014