Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Inhalation Injury; Pneumonitis
• Intervention / Treatment: Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: bronchoscopy intervention group; Group undergoing scheduled bronchoscopy.	Procedure: bronchoscopy; Scheduled bronchoscopy.
NO_INTERVENTION: Control group; Standard treatment without scheduled bronchoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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).	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

Collaborators and Investigators

• Sponsor: Hurley Medical Center
• Investigators: Principal Investigator: John A Carr, MD, Hurley Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (ACTUAL): July 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: October 15, 2009
• First Submitted That Met QC Criteria: October 16, 2009
• First Posted (ESTIMATE): October 19, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): January 31, 2013
• Last Update Submitted That Met QC Criteria: December 22, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: bronchoscopy; pneumonia; inhalation; burn
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Aspiration; Pneumonia; Wounds and Injuries
• Other Study ID Numbers: HMC0001