Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients
The investigators hypothesize that the scheduled use of bronchoscopy on a regular basis after inhalation injury in burn patients will improve outcome by providing pulmonary hygiene, decrease the incidence of pneumonia, and detect pneumonia earlier than standard treatment without bronchoscopy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients|
- All Cause Mortality [ Time Frame: until death or discharge from hospital, data reviewed every 6 months ] [ Designated as safety issue: No ]Bronchoscopy group deaths n=0. Control group deaths n=1.
- Respiratory Associated Mortality [ Time Frame: until death or discharge from hospital, data reviewed every 6 months ] [ Designated as safety issue: No ]Bronchoscopy group deaths n=0. Control group deaths n=1.
- Incidence of Pneumonia [ Time Frame: until discharge from the hospital, data reviewed every 6 months ] [ Designated as safety issue: No ]Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)
- Length of Mechanical Ventilation [ Time Frame: until discharge from hospital, data reviewed every 6 months ] [ Designated as safety issue: No ]Days of mechanical ventilation (bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).
- Length of ICU Stay [ Time Frame: until discharge from hospital, data reviewed every 6 months ] [ Designated as safety issue: No ]Number of ICU days (bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).
- Length of Hospital Stay [ Time Frame: until discharge from hospital, data reviewed every 6 months ] [ Designated as safety issue: No ]Number of hospital days (bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).
|Study Start Date:||October 2009|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: bronchoscopy intervention group
Group undergoing scheduled bronchoscopy.
No Intervention: Control group
Standard treatment without scheduled bronchoscopy.
The role of bronchoscopy in most hospitals has been limited to obtaining lavage fluid for culture and assessing the degree of airway injury, which has been shown to be predictive of outcome. Severe inhalation injury, which is characterized by pulmonary edema, bronchial edema, and secretions, can occlude the airway and lead to atelectasis and pneumonia. Aggressive use of bronchoscopy is highly effective in removing foreign particles and accumulated secretions that worsen the inflammatory response and impede ventilation. While it seems intuitive that bronchoscopy would improve pulmonary hygiene by removing secretions and denuded epithelial slough in burn patients, there has not been any published data to support or deter the use of bronchoscopy for inhalation injury nor document an improvement in morbidity or mortality secondary to bronchoscopy as a therapeutic intervention.
Recent research has shown that the process of intubation for mechanical ventilation provides a portal for bacterial contamination, after which the damaged tracheobronchial mucosa quickly becomes colonized with pathogenic organisms in over 50% of the patients. Furthermore, within 15 minutes of smoke inhalation, there is significant airway edema and thickening, more prominently in the lower trachea than the upper portion. These factors place the patient with inhalation injury at high risk for pneumonia.
We have used the National Burn Repository data to previously show that patients who receive aggressive use of bronchoscopy after inhalation injury have an improved outcome in terms of decreased ventilator days, decreased ICU length of stay, decreased incidence of pneumonia, and a trend towards improved mortality. However, that data was unable to document why. It was also unable to confirm that the findings were not due to institutional bias. Therefore, one of the conclusions from that study was that a prospective trial is needed to confirm the findings.
Our hypothesis is that a scheduled and sequential use of bronchoscopy after inhalation injury as a therapeutic tool to remove secretions, slough, carbonaceous material, and screen for the early detection of pneumonia by bronchoalveolar lavage (BAL) will improve outcome. We will attempt to document this improvement by using the following endpoints: length of ICU stay, length of hospital stay, ventilator days, incidence of pneumonia, overall morbidity and mortality with and without bronchoscopy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997555
|United States, Michigan|
|Hurley Medical Center|
|Flint, Michigan, United States, 48503|
|Principal Investigator:||John A Carr, MD||Hurley Medical Center|