Airway Obstruction Clinical Trial
Official title:
Mackay Memorial Hospital
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 95 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Taiwan | Mackay Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Mackay Memorial Hospital |
Taiwan,
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. — View Citation
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. Erratum in: Crit Care Med. 2007 May;35(5):1454 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
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