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Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation

Primary Purpose

Bronchial Asthma

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Fiberoptic bronchoscopy
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchial Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oslo University Hospital - Ulleval

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LF tests, Fiberoptic bronchoscopy

Arm Description

Spirometry, Peak Expiratory Flow (PEF). Bronchoscopic assessment of soot in central airways.

Outcomes

Primary Outcome Measures

Positive metacholine test (bronchial hyperreactivity).
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.

Secondary Outcome Measures

Full Information

First Posted
November 10, 2010
Last Updated
September 26, 2016
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01240707
Brief Title
Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation
Official Title
Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LF tests, Fiberoptic bronchoscopy
Arm Type
Other
Arm Description
Spirometry, Peak Expiratory Flow (PEF). Bronchoscopic assessment of soot in central airways.
Intervention Type
Other
Intervention Name(s)
Fiberoptic bronchoscopy
Other Intervention Name(s)
Bronchopscopy
Intervention Description
Fiberoptic bronchoscopy performed to remove secretions and assess soot in central airways
Primary Outcome Measure Information:
Title
Positive metacholine test (bronchial hyperreactivity).
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Espen R Nakstad, MD
Organizational Affiliation
Oslo University Hospital - Ulleval, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Helge Opdahl, MD, PhD
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Oslo University Hospital - Ulleval
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation

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