Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pathophysiologic Changes in the Respiratory System After Fire Smoke Inhalation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Espen Rostrup Nakstad, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01240707
First received: November 10, 2010
Last updated: January 12, 2013
Last verified: May 2011
  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: Single Blind (Investigator)
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 Oslo University Hospital:

Primary Outcome Measures:
  • Positive metacholine test (bronchial hyperreactivity). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lung function tests, 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240707

Contacts
Contact: Espen R Nakstad, MD +47 22 11 91 01 naes@uus.no

Locations
Norway
Oslo University Hospital - Ulleval Recruiting
Oslo, Norway, 0407
Contact: Espen R Nakstad, MD    +47 22 11 91 01    naes@uus.no   
Contact: Helge Opdahl, MD, PhD    +47 22 11 91 01    heop@uus.no   
Principal Investigator: Espen R Nakstad, MD         
Sub-Investigator: Ole H Skjoensberg, MD, PhD         
Sub-Investigator: Fredrik Borchsenius, MD         
Sub-Investigator: Helge Opdahl, MD, PhD         
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Espen R Nakstad, MD Oslo University Hospital - Ulleval, Norway
Study Director: Helge Opdahl, MD, PhD Oslo University Hospital Ulleval
  More Information

No publications provided

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
Study First Received: November 10, 2010
Last Updated: January 12, 2013
Health Authority: Norway: Regional Ethics Commitee

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

ClinicalTrials.gov processed this record on November 25, 2014