Inhalation Injury, Pneumonia, Pneumonitis
Conditions
Keywords
inhalation, bronchoscopy, burn, pneumonia
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREbronchoscopy
Scheduled bronchoscopy.
Sponsors
Hurley Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality | until death or discharge from hospital, data reviewed every 6 months | Bronchoscopy group deaths n=0. Control group deaths n=1. |
| Respiratory Associated Mortality | until death or discharge from hospital, data reviewed every 6 months | Bronchoscopy group deaths n=0. Control group deaths n=1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Pneumonia | until discharge from the hospital, data reviewed every 6 months | Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%) |
| Length of Mechanical Ventilation | 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). |
| Length of ICU Stay | 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). |
| Length of Hospital Stay | 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). |
Countries
United States
Participant flow
Recruitment details
From 2009-2012, 33 patients with inhalation injury were admitted to our regional burn center.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Control Group Standard treatment without scheduled bronchoscopy. | 15 |
| Total | 28 |
Baseline characteristics
| Characteristic | Bronchoscopy Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 0 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 15 Participants | 23 Participants |
| Age Continuous | 51 years STANDARD_DEVIATION 11 | 35 years STANDARD_DEVIATION 8 | 42 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 13 participants | 15 participants | 28 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 |
Outcome results
Primary
All Cause Mortality
Bronchoscopy group deaths n=0. Control group deaths n=1.
Time frame: until death or discharge from hospital, data reviewed every 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bronchoscopy Intervention Group | All Cause Mortality | 0 participants |
| Control Group | All Cause Mortality | 1 participants |
Primary
Respiratory Associated Mortality
Bronchoscopy group deaths n=0. Control group deaths n=1.
Time frame: until death or discharge from hospital, data reviewed every 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bronchoscopy Intervention Group | Respiratory Associated Mortality | 0 participants |
| Control Group | Respiratory Associated Mortality | 1 participants |
Secondary
Incidence of Pneumonia
Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)
Time frame: until discharge from the hospital, data reviewed every 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bronchoscopy Intervention Group | Incidence of Pneumonia | 4 participants |
| Control Group | Incidence of Pneumonia | 6 participants |
p-value: 0.6Chi-squared
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).
Time frame: until discharge from hospital, data reviewed every 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bronchoscopy Intervention Group | Length of Hospital Stay | 21 days |
| Control Group | Length of Hospital Stay | 26 days |
p-value: 0.5t-test, 2 sided
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).
Time frame: until discharge from hospital, data reviewed every 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bronchoscopy Intervention Group | Length of ICU Stay | 10 days |
| Control Group | Length of ICU Stay | 18 days |
p-value: 0.4t-test, 2 sided
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).
Time frame: until discharge from hospital, data reviewed every 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bronchoscopy Intervention Group | Length of Mechanical Ventilation | 5.1 days |
| Control Group | Length of Mechanical Ventilation | 6.7 days |
p-value: 0.7t-test, 2 sided