Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients

• Sponsor: Hurley Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00997555
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inhalation Injury; Pneumonitis; Pneumonia	Procedure: bronchoscopy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bronchoscopy intervention group Group undergoing scheduled bronchoscopy.	Procedure: bronchoscopy; Scheduled bronchoscopy.
No Intervention: Control group Standard treatment without scheduled bronchoscopy.

Outcome Measures

Primary Outcome Measures

1. All Cause Mortality [until death or discharge from hospital, data reviewed every 6 months]

   Bronchoscopy group deaths n=0. Control group deaths n=1.

2. 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 Outcome Measures

1. Incidence of Pneumonia [until discharge from the hospital, data reviewed every 6 months]

   Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)

2. 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).

3. 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).

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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hurley Medical Center	Flint	Michigan	United States	48503

Sponsors and Collaborators

• Hurley Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hurley Medical Center
• ClinicalTrials.gov Identifier: NCT00997555
• Other Study ID Numbers: HMC0001
• First Posted: Oct 19, 2009
• Last Update Posted: Jan 31, 2013
• Last Verified: Dec 1, 2012

• Keywords provided by Hurley Medical Center: inhalation; bronchoscopy; burn; pneumonia
• Additional relevant MeSH terms: Pneumonia; Respiratory Aspiration; Wounds and Injuries

Study Results

Participant Flow

Recruitment Details	From 2009-2012, 33 patients with inhalation injury were admitted to our regional burn center.
Pre-assignment Detail	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.

Arm/Group Title	Bronchoscopy Intervention Group	Control Group
Arm/Group Description	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.	Standard treatment without scheduled bronchoscopy.
Period Title: Overall Study
STARTED	13	15
COMPLETED	13	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Bronchoscopy Intervention Group	Control Group	Total
Arm/Group Description	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.	Standard treatment without scheduled bronchoscopy.	Total of all reporting groups
Overall Participants	13	15	28
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 61.5%	15 100%	23 82.1%
>=65 years	5 38.5%	0 0%	5 17.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51 (11)	35 (8)	42 (9)
Sex: Female, Male (Count of Participants)
Female	2 15.4%	3 20%	5 17.9%
Male	11 84.6%	12 80%	23 82.1%
Region of Enrollment (participants) [Number]
United States	13 100%	15 100%	28 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bronchoscopy Intervention Group	Control Group
Arm/Group Description	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.	Standard treatment without scheduled bronchoscopy.
Measure Participants	13	15
Number [participants]	0 0%	1 6.7%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bronchoscopy Intervention Group	Control Group
Arm/Group Description	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.	Standard treatment without scheduled bronchoscopy.
Measure Participants	13	15
Number [participants]	0 0%	1 6.7%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bronchoscopy Intervention Group	Control Group
Arm/Group Description	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.	Standard treatment without scheduled bronchoscopy.
Measure Participants	13	15
Number [participants]	4 30.8%	6 40%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bronchoscopy Intervention Group, Control Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6
	Comments
	Method	Chi-squared
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bronchoscopy Intervention Group	Control Group
Arm/Group Description	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.	Standard treatment without scheduled bronchoscopy.
Measure Participants	13	15
Median (95% Confidence Interval) [days]	5.1	6.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bronchoscopy Intervention Group, Control Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7
	Comments	(bronchoscopy 5.1 days, 95% CI +/- 3.6 days versus control 6.7 days, 95% CI +/- 6.3 days, p = 0.7).
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bronchoscopy Intervention Group	Control Group
Arm/Group Description	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.	Standard treatment without scheduled bronchoscopy.
Measure Participants	13	15
Median (95% Confidence Interval) [days]	10	18

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bronchoscopy Intervention Group, Control Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4
	Comments
	Method	t-test, 2 sided
	Comments	(bronchoscopy 10 days, 95% CI +/- 10 days versus control 18 days, 95% CI +/- 12 days, p = 0.4).

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bronchoscopy Intervention Group	Control Group
Arm/Group Description	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.	Standard treatment without scheduled bronchoscopy.
Measure Participants	13	15
Median (95% Confidence Interval) [days]	21	26

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bronchoscopy Intervention Group, Control Group
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5
	Comments
	Method	t-test, 2 sided
	Comments	(bronchoscopy 21 days, 95% CI +/- 12 days versus control 26 days, 95% CI +/- 12 days, p = 0.5).

Adverse Events

Arm/Group Title	Bronchoscopy Intervention Group		Control Group
Arm/Group Description	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.		Standard treatment without scheduled bronchoscopy.
All Cause Mortality
	Bronchoscopy Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bronchoscopy Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Bronchoscopy Intervention Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.