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.
Materials and methods Patients The current study included patients admitted to the adult
medical ICU of the Mackay Memorial Medical Center from 1 October 2004 and 1 July 2007 and
who met the inclusion criteria described below. Informed consent was obtained from the
patients or their relatives prior to entering the trial. This study was approved by the
Institutional Research Ethics Board. The cuff-leak test was therefore administered to
patients requiring mechanical ventilation for more than 48 hours. 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 were: 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. All patients were intubated with a high-volume, low-pressure cuffed ETT.
Patients exhibiting excessive movement were sedated or paralyzed during mechanical
ventilation. Routine nursing care included ETT suctioning every 2 hours or as needed to
maintain a patent airway. Patients were mechanically ventilated in the volume-assisted
control mode with a tidal volume of 10 mL/kg of ideal body weight, a respiratory rate of 20
breaths/minute, and a zero PEEP during CLV measurement. The operator-selected inspiratory
tidal volume of 10 mL per kilogram of ideal body weight, displayed as an expiratory tidal
volume, was recorded. The balloon cuff was deflated, the expiratory tidal volume was
recorded over the 6 subsequent respiratory cycles, and the average of the lowest 3 values
was utilized for subsequent analyses. The CLV was determined as the difference in the actual
tidal volume before and after cuff deflation.
Study protocol Patients requiring mechanical ventilation for > 48 hours and exhibiting a CLV
< 110 mL were therefore included in the trial. The study was prospective, randomized,
double-blind, and placebo-controlled. The randomization procedure was performed by a
respiratory therapist not involved in patient care using blocked randomization. Patients
were randomized to receive intravenous dexamethasone 5 mg per injection, or intravenous
normal saline at an equivalent volume. Dexamethasone or normal saline (placebo) was
administered every 6 hours for a total of 4 doses. Cuff leak tests were measured one hour
after each injection and 24 hours after the 4th injection of dexamethasone or placebo. Both
the physician and the staff who administered the treatment were blinded. The ICU physicians
were not apprised of the measurements obtained by the respiratory therapist. Extubation was
carried out 24 hours after the last injection of intervention fluid. After extubation, the
presence of an audible, high-pitched wheeze was an indication for the inhalation of racemic
epinephrine.
Patients meeting at least two of the following criteria were assigned to take non-invasive
positive-pressure ventilation by face mask: 1) respiratory acidosis (defined as an arterial
pH < 7.35 with a partial pressure of arterial carbon dioxide > 45 mm Hg), 2) clinical signs
suggestive of respiratory-muscle fatigue or increased respiratory effort (i.e., use of
accessory muscles, intercostal retraction, or paradoxical motion of the abdomen), 3) a
respiratory rate > 25 breaths per minute for 2 consecutive hours, and 4) hypoxemia (defined
as an arterial oxygen saturation of < 90 % or a PaO2 of < 80 mm Hg with a FiO2 > 0.50).
Patients were re-intubated with mechanical ventilation support if they met at least one of
the following criteria: 1) pH < 7.3 with a partial pressure of carbon dioxide increase > 15
mm Hg, 2) a change in mental status rendering the patient unable to tolerate non-invasive
ventilation, 3) a decrease in the oxygen saturation to < 85% despite the use of a high
fraction of inspired oxygen (a PaO2 < 50 mm Hg with a FiO2 > 70 %), 4) lack of improvement
in signs of respiratory-muscle fatigue, 5) hypotension with a SBP < 80 mm Hg for more than
30 minutes despite adequate volume challenge, 6) a diastolic blood pressure drop > 20 mm Hg,
and 7) copious secretions that could not be adequately cleared or that were associated with
acidosis, hypoxemia, or changes in mental status (somnolence, agitation, or diaphoresis).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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