Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients

Pneumonia Clinical Trial

Official title:

Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997555
• Other study ID #: HMC0001
• Status: Completed
• Phase: N/A
• First received: October 15, 2009
• Last updated: December 22, 2012
• Start date: October 2009
• Est. completion date: July 2012

Study information

• Verified date: December 2012
• Source: Hurley Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inhalation Injury
• Pneumonia
• Pneumonitis
• Respiratory Aspiration

Intervention

Procedure:
• bronchoscopy
Scheduled bronchoscopy.

Locations

Country	Name	City	State
United States	Hurley Medical Center	Flint	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Hurley Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cause Mortality	Bronchoscopy group deaths n=0. Control group deaths n=1.	until death or discharge from hospital, data reviewed every 6 months	No
Primary	Respiratory Associated Mortality	Bronchoscopy group deaths n=0. Control group deaths n=1.	until death or discharge from hospital, data reviewed every 6 months	No
Secondary	Incidence of Pneumonia	Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)	until discharge from the hospital, data reviewed every 6 months	No
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).	until discharge from hospital, data reviewed every 6 months	No
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).	until discharge from hospital, data reviewed every 6 months	No
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).	until discharge from hospital, data reviewed every 6 months	No