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Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients

Primary Purpose

Inhalation Injury, Pneumonitis, Pneumonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bronchoscopy
Sponsored by
Hurley Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inhalation Injury focused on measuring inhalation, bronchoscopy, burn, pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hurley Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

bronchoscopy intervention group

Control group

Arm Description

Group undergoing scheduled bronchoscopy.

Standard treatment without scheduled bronchoscopy.

Outcomes

Primary Outcome Measures

All Cause Mortality
Bronchoscopy group deaths n=0. Control group deaths n=1.
Respiratory Associated Mortality
Bronchoscopy group deaths n=0. Control group deaths n=1.

Secondary Outcome Measures

Incidence of Pneumonia
Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)
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).
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).
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).

Full Information

First Posted
October 15, 2009
Last Updated
December 22, 2012
Sponsor
Hurley Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00997555
Brief Title
Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients
Official Title
Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hurley Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalation Injury, Pneumonitis, Pneumonia
Keywords
inhalation, bronchoscopy, burn, pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bronchoscopy intervention group
Arm Type
Experimental
Arm Description
Group undergoing scheduled bronchoscopy.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard treatment without scheduled bronchoscopy.
Intervention Type
Procedure
Intervention Name(s)
bronchoscopy
Intervention Description
Scheduled bronchoscopy.
Primary Outcome Measure Information:
Title
All Cause Mortality
Description
Bronchoscopy group deaths n=0. Control group deaths n=1.
Time Frame
until death or discharge from hospital, data reviewed every 6 months
Title
Respiratory Associated Mortality
Description
Bronchoscopy group deaths n=0. Control group deaths n=1.
Time Frame
until death or discharge from hospital, data reviewed every 6 months
Secondary Outcome Measure Information:
Title
Incidence of Pneumonia
Description
Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)
Time Frame
until discharge from the hospital, data reviewed every 6 months
Title
Length of Mechanical Ventilation
Description
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
Title
Length of ICU Stay
Description
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
Title
Length of Hospital Stay
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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: Likely to die within 48 hours based upon severity of injury. Less than 18 years old. Burned patient transferred to our facility already on mechanical ventilation for more than 48 hours. Patient already on antibiotics for another reason.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A Carr, MD
Organizational Affiliation
Hurley Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States

12. IPD Sharing Statement

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Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients

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