Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452062
Status:
UNKNOWN
Last Update Posted:
2007-03-26
First Post:
2007-03-23
Brief Title:
Dexamethasone and the Prevention of Post-Extubation Airway Obstruction in Adults
Sponsor:
Mackay Memorial Hospital
Organization:
Mackay Memorial Hospital
Study Overview
Official Title:
Mackay Memorial Hospital
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 38C 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 06 PaO2 60 and partial pressure of oxygen PaO2FiO2 ratio 200 6 positive end-expiratory pressure PEEP 5 cm H2O 7 rapid and shallow ratio of frequency to tidal volume fVT 105 8 minute ventilation 15 Lmin and 9 pH 73 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 ie 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 ie PaO2 60 mm Hg with a FiO2 050 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 mLkg of ideal body weight a respiratory rate of 20 breathsminute 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 735 with a partial pressure of arterial carbon dioxide 45 mm Hg 2 clinical signs suggestive of respiratory-muscle fatigue or increased respiratory effort ie 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 050 Patients were re-intubated with mechanical ventilation support if they met at least one of the following criteria 1 pH 73 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
Exclusion criteria were 1 the need for more than one tracheal intubation during the hospital stay 2 unstable hemodynamics ie 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 ie PaO2 60 mm Hg with a FiO2 050 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 mLkg of ideal body weight a respiratory rate of 20 breathsminute 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 735 with a partial pressure of arterial carbon dioxide 45 mm Hg 2 clinical signs suggestive of respiratory-muscle fatigue or increased respiratory effort ie 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 050 Patients were re-intubated with mechanical ventilation support if they met at least one of the following criteria 1 pH 73 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None