Inhalation InjuryNCT00997555
Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients
A study testing bronchoscopy in people with Inhalation Injury and Pneumonitis, run by Hurley Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inhalation Injury, Pneumonitis, Pneumonia
- What is being tested?
- bronchoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Inhalation Injury, Pneumonitis, Pneumonia
- Being tested
- bronchoscopy
- Keywords
- inhalation, bronchoscopy, burn, pneumonia
- Medical subject headings
- Pneumonia, Respiratory Aspiration, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopyProcedure or surgery
Scheduled bronchoscopy.
| Study group | Role | What they receive |
|---|---|---|
| bronchoscopy intervention group | Experimental | Group undergoing scheduled bronchoscopy. Receives: Procedure: bronchoscopy |
| Control group | No intervention | Standard treatment without scheduled bronchoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Cause Mortality
Bronchoscopy group deaths n=0. Control group deaths n=1.
Measured: until death or discharge from hospital, data reviewed every 6 months
Respiratory Associated Mortality
Bronchoscopy group deaths n=0. Control group deaths n=1.
Measured: until death or discharge from hospital, data reviewed every 6 months
Secondary outcomes (4)
Incidence of Pneumonia
Bronchoscopy group- 4/13 (31%) Control group- 6/15 (40%)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: until discharge from hospital, data reviewed every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inhalation InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hurley Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John A Carr, MD, Principal investigator, Hurley Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997555
- Sponsor's protocol ID
- HMC0001
- Status last verified
- Dec 2012
- First submitted
- 15 Oct 2009
- Last updated
- 31 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Bronchoscopy After Inhalation Injury in Burn Patients
- ClinicalTrials.gov ID
- NCT00997555
- Acronym / sponsor ID
- HMC0001
- Conditions
- Inhalation Injury, Pneumonitis, Pneumonia
- Keywords
- inhalation, bronchoscopy, burn, pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hurley Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Posted 31 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bronchoscopy intervention group | Experimental | Procedure: bronchoscopyGroup undergoing scheduled bronchoscopy. |
| Control group | No intervention | –Standard treatment without scheduled bronchoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchoscopyScheduled bronchoscopy. | Procedure or surgery | bronchoscopy intervention group |
Primary outcome
All Cause Mortality
Time frame: until death or discharge from hospital, data reviewed every 6 months
Bronchoscopy group deaths n=0. Control group deaths n=1.
Respiratory Associated Mortality
Time frame: until death or discharge from hospital, data reviewed every 6 months
Bronchoscopy group deaths n=0. Control group deaths n=1.
4 secondary outcomes
Incidence of Pneumonia
Time frame: until discharge from the hospital, data reviewed every 6 months
Length of Mechanical Ventilation
Time frame: until discharge from hospital, data reviewed every 6 months
Length of ICU Stay
Time frame: until discharge from hospital, data reviewed every 6 months
Length of Hospital Stay
Time frame: until discharge from hospital, data reviewed every 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Carr, MD principal investigator
Hurley Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchoscopy in people with Inhalation Injury and Pneumonitis, run by Hurley Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All Cause Mortality (time frame: until death or discharge from hospital, data reviewed every 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.