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

NCT00452062 | Unknown Phase 2 DMC

• 1 other identifier: MMH-I-S-106
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Obstruction

Keywords

cuff-leak test; intubation; corticosteroids; dexamethasone to reduce the occurrence of post-extubation airway obstruction

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

Dexamethasone DRUG

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The need for more than one tracheal intubation during the hospital stay,
• 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),
• Profound recalcitrant hypoxemia (i.e., PaO2 \< 60 mm Hg with a FiO2 \> 0.50), or
• Administration of corticosteroids 7 days prior to extubation.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taipei, 104, Taiwan

RECRUITING

Related Publications (4)

• 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.

  PMID: 16540947 RESULT

• Anene O, Meert KL, Uy H, Simpson P, Sarnaik AP. Dexamethasone for the prevention of postextubation airway obstruction: a prospective, randomized, double-blind, placebo-controlled trial. Crit Care Med. 1996 Oct;24(10):1666-9. doi: 10.1097/00003246-199610000-00011.

  PMID: 8874303 RESULT

• Chung YH, Chao TY, Chiu CT, Lin MC. The cuff-leak test is a simple tool to verify severe laryngeal edema in patients undergoing long-term mechanical ventilation. Crit Care Med. 2006 Feb;34(2):409-14. doi: 10.1097/01.ccm.0000198105.65413.85.

  PMID: 16424722 RESULT

• 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.

  PMID: 17605780 DERIVED

MeSH Terms

Conditions

Airway Obstruction

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Chao-Hsien Lee, MD

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Hsien Lee, MD

CONTACT

+886-2-23926589; L49428@ms2.mmh.org.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 23, 2007
• First Posted: March 26, 2007
• Study Start: October 1, 2004
• Study Completion: July 1, 2007
• Last Updated: March 26, 2007

Record last verified: 2007-03

Locations

TW (1)