Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation
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|ClinicalTrials.gov Identifier: NCT01240707|
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : September 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Bronchial Asthma||Other: Fiberoptic bronchoscopy||Not Applicable|
Fire smoke inhalation may contribute to intrabronchial inflammation, airway obstruction and impaired gas exchange. The scope of injury in fire smoke victims ranges from cough and minor airway irritation to severe respiratory failure and long term mechanical ventilation in the Intensive Care Unit. Some patients with high HbCO-levels are also treated with hyperbaric oxygen therapy.
In this study the investigators will examine if the scope of inhalation injury can be assessed soon after admission based on clinical markers, biochemical markers, Peak Expiratory Flow (PEF), spirometry and bronchoscopy. The clinical effect of fiberoptic bronchoscopy after severe smoke inhalation will also be examined. At 6 months a lung function test and metacholine test will be performed to examine whether they have developed asthma/increased bronchial hyperreactivity or not after the initial fire smoke exposure. Lab staff (flowcytometer and cytokine analysis) are unaware of patient identity and whether the patient is a smoke-exposed patient or a healthy volunteer in the control group of non-exposed persons.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
LF tests, Fiberoptic bronchoscopy
Spirometry, Peak Expiratory Flow (PEF). Bronchoscopic assessment of soot in central airways.
Other: Fiberoptic bronchoscopy
Fiberoptic bronchoscopy performed to remove secretions and assess soot in central airways
Other Name: Bronchopscopy
- Positive metacholine test (bronchial hyperreactivity). [ Time Frame: 6 months ]At 6 months a lung function test and metacholine test will be performed to examine whether patients have developed asthma/increased bronchial hyperreactivity after the initial fire smoke exposure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240707
|Oslo University Hospital - Ulleval|
|Oslo, Norway, 0407|
|Principal Investigator:||Espen R Nakstad, MD||Oslo University Hospital - Ulleval, Norway|
|Study Director:||Helge Opdahl, MD, PhD||Ullevaal University Hospital|