Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation

Bronchial Asthma Clinical Trial

Official title:

Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240707
• Other study ID #: REK S-O, Ref 2010/1340, part A
• Status: Completed
• Phase: N/A
• First received: November 10, 2010
• Last updated: September 26, 2016
• Start date: November 2010
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma
• Smoke Inhalation Injury

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital - Ulleval	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes