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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00452062
Recruitment Status : Unknown
Verified March 2007 by Mackay Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : March 26, 2007
Last Update Posted : March 26, 2007
Information provided by:
Mackay Memorial Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Airway Obstruction Drug: Dexamethasone Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Mackay Memorial Hospital
Study Start Date : October 2004
Estimated Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00452062

Contact: Chao-Hsien Lee, MD +886-2-23926589

Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 104
Contact: Wan-Ting Chen, Ms    +886-2-25433535 ext 2003   
Principal Investigator: Chao-Hsien Lee, MD         
Sponsors and Collaborators
Mackay Memorial Hospital
Principal Investigator: Chao-Hsien Lee, MD Mackay Memorial Hospital

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00452062     History of Changes
Other Study ID Numbers: MMH-I-S-106
First Posted: March 26, 2007    Key Record Dates
Last Update Posted: March 26, 2007
Last Verified: March 2007

Keywords provided by Mackay Memorial Hospital:
cuff-leak test
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
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action