Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation
Recruitment status was Recruiting
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
|Official Title:||Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation|
- Positive metacholine test (bronchial hyperreactivity). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Lung function tests, 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240707
|Contact: Espen R Nakstad, MD||+47 22 11 91 firstname.lastname@example.org|
|Oslo University Hospital - Ulleval||Recruiting|
|Oslo, Norway, 0407|
|Contact: Espen R Nakstad, MD +47 22 11 91 01 email@example.com|
|Contact: Helge Opdahl, MD, PhD +47 22 11 91 01 firstname.lastname@example.org|
|Principal Investigator: Espen R Nakstad, MD|
|Sub-Investigator: Ole H Skjoensberg, MD, PhD|
|Sub-Investigator: Fredrik Borchsenius, MD|
|Sub-Investigator: Helge Opdahl, MD, PhD|
|Principal Investigator:||Espen R Nakstad, MD||Oslo University Hospital - Ulleval, Norway|
|Study Director:||Helge Opdahl, MD, PhD||Oslo University Hospital Ulleval|