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Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01240707
First Posted: November 15, 2010
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Espen Rostrup Nakstad, Oslo University Hospital
  Purpose
Fire smoke inhalation may contribute to intrabronchial inflammation, airway obstruction and impaired gas exchange. In this study the investigators will examine if the scope of inhalation injury can be assessed soon after hospital admission based on clinical markers, biochemical markers, Peak Expiratory Flow (PEF), spirometry and bronchoscopy. At 6 months a lung function test and metacholine test will be performed to examine whether patients have developed increased bronchial hyperreactivity (asthma) or not after the initial fire smoke exposure.

Condition Intervention
Bronchial Asthma Other: Fiberoptic bronchoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation

Resource links provided by NLM:


Further study details as provided by Espen Rostrup Nakstad, Oslo University Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 40
Study Start Date: November 2010
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • fire smoke exposed patient
  • > 18 years of age
  • admitted to hospital

Exclusion Criteria:

  • < 18 years of ager
  • trauma patient

Control group (healthy volunteers/hospital staff):

  • > 18 years of age
  • non-smoker
  • no exposure to fire smoke
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Norway
Oslo University Hospital - Ulleval
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Espen R Nakstad, MD Oslo University Hospital - Ulleval, Norway
Study Director: Helge Opdahl, MD, PhD Ullevaal University Hospital
  More Information

Responsible Party: Espen Rostrup Nakstad, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01240707     History of Changes
Other Study ID Numbers: REK S-O, Ref 2010/1340, part A
First Submitted: November 10, 2010
First Posted: November 15, 2010
Last Update Posted: September 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Asthma
Smoke Inhalation Injury
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Burns, Inhalation
Burns
Wounds and Injuries
Respiratory System Agents