Trial Outcomes & Findings for Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients (NCT NCT00997555)

NCT ID: NCT00997555

Last Updated: 2013-01-31

Results Overview

Bronchoscopy group deaths n=0. Control group deaths n=1.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: until death or discharge from hospital, data reviewed every 6 months
• Results posted on: 2013-01-31

Participant Flow

From 2009-2012, 33 patients with inhalation injury were admitted to our regional burn center.

Five were never enrolled. Two patient's families refused to consent, and two fell into exclusion criteria number 1. Both died within six hours of admission. The remaining fifth patient self-extubated and thus failed to meet inclusion criteria number 1. This left 28 patients for analysis, all of whom were enrolled and randomized into the study.

Participant milestones

Measure	Bronchoscopy Intervention Group Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (\> 100K CFU/ml) were treated with antibiotics according to sensitivites.	Control Group Standard treatment without scheduled bronchoscopy.
Overall Study STARTED	13	15
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients

Baseline characteristics by cohort

Measure	Bronchoscopy Intervention Group n=13 Participants Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (\> 100K CFU/ml) were treated with antibiotics according to sensitivites.	Control Group n=15 Participants Standard treatment without scheduled bronchoscopy.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Age Continuous	51 years STANDARD_DEVIATION 11 • n=5 Participants	35 years STANDARD_DEVIATION 8 • n=7 Participants	42 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: until death or discharge from hospital, data reviewed every 6 months

Bronchoscopy group deaths n=0. Control group deaths n=1.

Outcome measures

Measure	Bronchoscopy Intervention Group n=13 Participants Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (\> 100K CFU/ml) were treated with antibiotics according to sensitivites.	Control Group n=15 Participants Standard treatment without scheduled bronchoscopy.
All Cause Mortality	0 participants	1 participants

PRIMARY outcome

Timeframe: until death or discharge from hospital, data reviewed every 6 months

Bronchoscopy group deaths n=0. Control group deaths n=1.

Outcome measures

Measure	Bronchoscopy Intervention Group n=13 Participants Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (\> 100K CFU/ml) were treated with antibiotics according to sensitivites.	Control Group n=15 Participants Standard treatment without scheduled bronchoscopy.
Respiratory Associated Mortality	0 participants	1 participants

SECONDARY outcome

Timeframe: until discharge from the hospital, data reviewed every 6 months

Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)

Outcome measures

Measure	Bronchoscopy Intervention Group n=13 Participants Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (\> 100K CFU/ml) were treated with antibiotics according to sensitivites.	Control Group n=15 Participants Standard treatment without scheduled bronchoscopy.
Incidence of Pneumonia	4 participants	6 participants

SECONDARY outcome

Timeframe: until discharge from hospital, data reviewed every 6 months

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).

Outcome measures

Measure	Bronchoscopy Intervention Group n=13 Participants Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (\> 100K CFU/ml) were treated with antibiotics according to sensitivites.	Control Group n=15 Participants Standard treatment without scheduled bronchoscopy.
Length of Mechanical Ventilation	5.1 days Interval 2.5 to 8.7	6.7 days Interval 0.4 to 13.0

SECONDARY outcome

Timeframe: until discharge from hospital, data reviewed every 6 months

Number of ICU days (bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).

Outcome measures

Measure	Bronchoscopy Intervention Group n=13 Participants Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (\> 100K CFU/ml) were treated with antibiotics according to sensitivites.	Control Group n=15 Participants Standard treatment without scheduled bronchoscopy.
Length of ICU Stay	10 days Interval 0.0 to 20.0	18 days Interval 6.0 to 30.0

SECONDARY outcome

Timeframe: until discharge from hospital, data reviewed every 6 months

Number of hospital days (bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).

Outcome measures

Measure	Bronchoscopy Intervention Group n=13 Participants Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (\> 100K CFU/ml) were treated with antibiotics according to sensitivites.	Control Group n=15 Participants Standard treatment without scheduled bronchoscopy.
Length of Hospital Stay	21 days Interval 9.0 to 33.0	26 days Interval 14.0 to 38.0

Adverse Events

Bronchoscopy Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Alfred Carr, MD

Hurley Medical Center

Phone: 810-262-4993

Email: heartandbones@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place