Dexamethasone and the Prevention of Post-Extubation Airway Obstruction in Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Mackay Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mackay Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00452062
First received: March 23, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

Laryngotracheal injury related to intubation may cause narrowing of the airway due to edema of the glottis. Post-extubation airway frequently necessitating re-intubation and resulting in the prolongation of intensive care. Factors correlating with the development of post-extubation stridor include age, female gender, an elevated Acute Physiologic and Chronic Health Evaluation II, trauma related to endotracheal intubation, excessive ETT size, unnecessary tube mobility, increased cuff pressure, frequent tracheal aspirations, infection, arterial hypotension, and a prolonged intubation period. Because the presence of an endotracheal tube (ETT) precludes direct visualization of the upper airway, recognition of edema due to laryngotracheal injury is often difficult. However, upper airway patency may be measured indirectly in the intubated patient by documentation of a leak around the ETT upon deflation of the sealing balloon cuff encircling the ETT. Controversy currently exists regarding the effectiveness of prophylactic steroid therapy for patients considered at high risk for post-extubation stridor. Only a limited number of prospective trials involving adults and evaluating the benefits of corticosteroid therapy prior to extubation have been conducted.

Studies regarding the efficacy of prophylactic corticosteroids for intubated patients have yielded conflicting results due to differences in the number of doses or types of corticosteroids administered.

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. The specific objectives were to determine whether multiple doses of dexamethasone are effective in the reduction or prevention of post-extubation airway obstruction in patients with a cuff leak volume (CLV) < 110 mL and to ascertain whether an aftereffect follows the discontinuation of dexamethasone.


Condition Intervention Phase
Airway Obstruction
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Mackay Memorial Hospital

Resource links provided by NLM:


Further study details as provided by Mackay Memorial Hospital:

Primary Outcome Measures:
  • The purpose of this study was to ascertain whether administration of multiple doses of dexamethasone to critically ill intubated patients reduces or prevents the occurrence of post-extubation airway obstruction.

Secondary Outcome Measures:
  • The secondary purpose of this study was to ascertain whether administration of multiple doses of dexamethasone to critically ill intubated patients reduces or prevents the occurrence of noninvasive ventilation or re-intubation.

Estimated Enrollment: 70
Study Start Date: October 2004
Estimated Study Completion Date: July 2007
  Show Detailed Description

  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. The need for more than one tracheal intubation during the hospital stay,
  2. Unstable hemodynamics (i.e., a mean SBP < 90 mm Hg, a SBP decrease > 40 mm Hg, or a mean arterial pressure [MAP] < 70 mm Hg),
  3. Profound recalcitrant hypoxemia (i.e., PaO2 < 60 mm Hg with a FiO2 > 0.50), or
  4. Administration of corticosteroids 7 days prior to extubation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00452062

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

Locations
Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 104
Contact: Wan-Ting Chen, Ms    +886-2-25433535 ext 2003    wanting.b352@ms1.mmh.org.tw   
Principal Investigator: Chao-Hsien Lee, MD         
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
Principal Investigator: Chao-Hsien Lee, MD Mackay Memorial Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00452062     History of Changes
Other Study ID Numbers: MMH-I-S-106
Study First Received: March 23, 2007
Last Updated: March 23, 2007
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Mackay Memorial Hospital:
cuff-leak test
intubation
corticosteroids
dexamethasone to reduce the occurrence of post-extubation airway obstruction

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

ClinicalTrials.gov processed this record on October 01, 2014