Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bronchoscopy intervention group | Experimental | Group undergoing scheduled bronchoscopy. |
|
| Control group | No Intervention | Standard treatment without scheduled bronchoscopy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bronchoscopy | Procedure | Scheduled bronchoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality | Bronchoscopy group deaths n=0. Control group deaths n=1. | until death or discharge from hospital, data reviewed every 6 months |
| Respiratory Associated Mortality | Bronchoscopy group deaths n=0. Control group deaths n=1. | until death or discharge from hospital, data reviewed every 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Pneumonia | Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%) | until discharge from the hospital, data reviewed every 6 months |
| 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). |
Not provided
Inclusion Criteria:
Any burned patient arriving intubated on mechanical ventilation OR requiring mechanical ventilation within 48 hours of admission AND
> 18 years old AND
patient believed to be able to survive more than 48 hours after arrival (not likely to be made DNR or comfort care) including:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John A Carr, MD | Hurley Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
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.
From 2009-2012, 33 patients with inhalation injury were admitted to our regional burn center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group | Standard treatment without scheduled bronchoscopy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All Cause Mortality | Bronchoscopy group deaths n=0. Control group deaths n=1. | Posted | Number | participants | until death or discharge from hospital, data reviewed every 6 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Alfred Carr, MD | Hurley Medical Center | 810-262-4993 | heartandbones@yahoo.com |
Not provided
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D053120 | Respiratory Aspiration |
| D002056 | Burns |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| until discharge from hospital, data reviewed every 6 months |
| 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 |
| 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 |
Standard treatment without scheduled bronchoscopy. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Respiratory Associated Mortality | Bronchoscopy group deaths n=0. Control group deaths n=1. | Posted | Number | participants | until death or discharge from hospital, data reviewed every 6 months |
|
|
|
| Secondary | Incidence of Pneumonia | Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%) | Posted | Number | participants | until discharge from the hospital, data reviewed every 6 months |
|
|
|
|
| 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). | Posted | Median | 95% Confidence Interval | days | until discharge from hospital, data reviewed every 6 months |
|
|
|
|
| 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). | Posted | Median | 95% Confidence Interval | days | until discharge from hospital, data reviewed every 6 months |
|
|
|
|
| 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). | Posted | Median | 95% Confidence Interval | days | until discharge from hospital, data reviewed every 6 months |
|
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Control Group | Standard treatment without scheduled bronchoscopy. | 0 | 15 | 0 | 15 |
Not provided
Not provided
Not provided
| D012120 |
| Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |