Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation

NCT ID: NCT01240707

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2016-05-31

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.

Conditions

Bronchial Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

LF tests, Fiberoptic bronchoscopy

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

Group Type: OTHER

Fiberoptic bronchoscopy

Intervention Type: OTHER

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

Interventions

Fiberoptic bronchoscopy

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

Intervention Type: OTHER

Other Intervention Names

Bronchopscopy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Espen Rostrup Nakstad

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Espen R Nakstad, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital - Ulleval, Norway

Helge Opdahl, MD, PhD

Role: STUDY_DIRECTOR

Ullevaal University Hospital

Locations

Oslo University Hospital - Ulleval

Oslo, Oslo County, Norway

Countries

Norway

Other Identifiers

REK S-O, Ref 2010/1340, part A

Identifier Type: -

Identifier Source: org_study_id