Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation

NCT01240707 | Completed

• 1 other identifier: REK S-O, Ref 2010/1340, part A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

LF tests, Fiberoptic bronchoscopy

OTHER

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

Other: Fiberoptic bronchoscopy

Interventions

Fiberoptic bronchoscopy OTHER

Fiberoptic bronchoscopy performed to remove secretions and assess soot in central airways

Also known as: Bronchopscopy

LF tests, Fiberoptic bronchoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \< 18 years of ager
• trauma patient
• Control group (healthy volunteers/hospital staff):
• \> 18 years of age
• non-smoker
• no exposure to fire smoke

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital - Ulleval

Oslo, Oslo County, 0407, Norway

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Espen R Nakstad, MD

  Oslo University Hospital - Ulleval, Norway

  PRINCIPAL INVESTIGATOR

• Helge Opdahl, MD, PhD

  Ullevaal University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 15, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 27, 2016

Record last verified: 2016-09

Locations

NO (1)