Pneumonia Clinical Trial
Official title:
Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients
Verified date | December 2012 |
Source | Hurley Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | July 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Any burned patient arriving intubated on mechanical ventilation OR requiring mechanical ventilation within 48 hours of admission AND 2. > 18 years old AND 3. patient believed to be able to survive more than 48 hours after arrival (not likely to be made DNR or comfort care) including: - any methamphetamine explosion or - any burn associated with fire (not chemical) of the face or blast injury to the face or - confined in a burning space for more than 10 minutes or - any burn with carbonaceous material around the nose or mouth or - any burn > 15% TBSA associated with fire (not chemical) or - any burn associated with an explosion in a confined space. Exclusion Criteria: 1. Likely to die within 48 hours based upon severity of injury. 2. Less than 18 years old. 3. Burned patient transferred to our facility already on mechanical ventilation for more than 48 hours. 4. Patient already on antibiotics for another reason. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Hurley Medical Center | Flint | Michigan |
Lead Sponsor | Collaborator |
---|---|
Hurley Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All Cause Mortality | Bronchoscopy group deaths n=0. Control group deaths n=1. | until death or discharge from hospital, data reviewed every 6 months | No |
Primary | Respiratory Associated Mortality | Bronchoscopy group deaths n=0. Control group deaths n=1. | until death or discharge from hospital, data reviewed every 6 months | No |
Secondary | Incidence of Pneumonia | Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%) | until discharge from the hospital, data reviewed every 6 months | No |
Secondary | Length of Mechanical Ventilation | 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). | until discharge from hospital, data reviewed every 6 months | No |
Secondary | Length of ICU Stay | Number of ICU days (bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4). | until discharge from hospital, data reviewed every 6 months | No |
Secondary | Length of Hospital Stay | Number of hospital days (bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5). | until discharge from hospital, data reviewed every 6 months | No |
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