Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094406
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2004-10-16
Brief Title:
Carbon Monoxide to Prevent Lung Inflammation
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Effects of Inhaled Carbon Monoxide on Pulmonary Inflammatory Responses Following Endotoxin Instillation
Status:
COMPLETED
Status Verified Date:
2016-04-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine in healthy volunteers how breathing carbon monoxide CO affects lung inflammation Severe lung inflammation sometimes develops in patients with pneumonia or patients who develop serious blood stream infections Studies in the laboratory and in animals show that CO can decrease lung inflammation
Healthy volunteers between 18 and 40 years of age who do not smoke are not taking any medications do not have asthma are not allergic to sulfa- and penicillin-based drugs and are not pregnant may be eligible for this study Candidates are screened with a medical history and physical examination blood and urine tests electrocardiogram EKG and chest x-ray Subjects are enrolled in either a pilot study or the main study
Participants undergo bronchoscopy and bronchoalveolar lavage to study the effects of endotoxin a component of bacteria that causes inflammation similar to that in patients with lung infections on lung function Before the procedure a small plastic tube catheter is placed in a vein to collect blood samples and another is placed in an artery to check blood pressure For the bronchoscopy the mouth and nasal airways are numbed with lidocaine and a bronchoscope thin flexible tube is passed through the nose into the airways of the lung A small amount of salt water is squirted through the bronchoscope into one lung and then salt water containing endotoxin is squirted into the other lung
Following the bronchoscopy subjects are treated with either CO or room air placebo for 6 hours Subjects in the pilot study receive treatment for only 3 hours The gas is delivered through a cushioned mask placed over the nose and mouth The amount of exhaled CO is measured before during and after inhalation of the gas For this measurement subjects take a deep breath to fill up their lungs and slowly exhale into a mouthpiece connected to a measuring device until they feel their lungs are empty
After the CO treatment a second bronchoscopy is done to examine how the lung responded to the CO or room air This is studied in two ways To sample the air a large needle is used to withdraw air through the bronchoscope over about 3 seconds Then the areas of the lung that were squirted with salt water alone and with endotoxin and salt water and are rinsed lavage and cells and secretions are collected
Healthy volunteers between 18 and 40 years of age who do not smoke are not taking any medications do not have asthma are not allergic to sulfa- and penicillin-based drugs and are not pregnant may be eligible for this study Candidates are screened with a medical history and physical examination blood and urine tests electrocardiogram EKG and chest x-ray Subjects are enrolled in either a pilot study or the main study
Participants undergo bronchoscopy and bronchoalveolar lavage to study the effects of endotoxin a component of bacteria that causes inflammation similar to that in patients with lung infections on lung function Before the procedure a small plastic tube catheter is placed in a vein to collect blood samples and another is placed in an artery to check blood pressure For the bronchoscopy the mouth and nasal airways are numbed with lidocaine and a bronchoscope thin flexible tube is passed through the nose into the airways of the lung A small amount of salt water is squirted through the bronchoscope into one lung and then salt water containing endotoxin is squirted into the other lung
Following the bronchoscopy subjects are treated with either CO or room air placebo for 6 hours Subjects in the pilot study receive treatment for only 3 hours The gas is delivered through a cushioned mask placed over the nose and mouth The amount of exhaled CO is measured before during and after inhalation of the gas For this measurement subjects take a deep breath to fill up their lungs and slowly exhale into a mouthpiece connected to a measuring device until they feel their lungs are empty
After the CO treatment a second bronchoscopy is done to examine how the lung responded to the CO or room air This is studied in two ways To sample the air a large needle is used to withdraw air through the bronchoscope over about 3 seconds Then the areas of the lung that were squirted with salt water alone and with endotoxin and salt water and are rinsed lavage and cells and secretions are collected
Detailed Description:
Acute respiratory distress syndrome ARDS is a major cause of morbidity and mortality Of the many potential predisposing factors sepsis and pneumonia represent the two main causes of ARDS In spite of an increase in survival in recent years mortality in patients with ARDS is still estimated around 30 to 40 In this context development of effective preventive strategies in patients at high risk of development of ARDS is of paramount importance Unfortunately the results of studies evaluating prophylactic regimens for ARDS have been mostly disappointing
The gaseous molecule carbon monoxide CO has been traditionally viewed as a toxic metabolic and industrial waste However recent studies have demonstrated an important physiologic role of CO in many biological systems Specifically strong anti-inflammatory anti-oxidant and anti-thrombotic effects of CO gas administration and heme oxygenase activation the enzyme that generates endogenous CO gas have been demonstrated in several animal models
Previous studies conducted in our department have demonstrated that bronchoscopic instillation of endotoxin LPS in healthy volunteers elicits a compartmentalized pulmonary inflammatory response serving as an excellent model to evaluate interventions directed towards suppression of lung inflammation at its earliest stages
In the current single blinded randomized placebo controlled study we are planning to evaluate the effects of inhaled carbon monoxide on local pulmonary inflammatory responses following endotoxin administration Healthy subjects will undergo local endotoxin instillation breathe CO or room air through a mask for 6 hours and then a repeat bronchoscopy with lavage will be done at 6 hours to assess the ability of CO to suppress local inflammation in the lung
The gaseous molecule carbon monoxide CO has been traditionally viewed as a toxic metabolic and industrial waste However recent studies have demonstrated an important physiologic role of CO in many biological systems Specifically strong anti-inflammatory anti-oxidant and anti-thrombotic effects of CO gas administration and heme oxygenase activation the enzyme that generates endogenous CO gas have been demonstrated in several animal models
Previous studies conducted in our department have demonstrated that bronchoscopic instillation of endotoxin LPS in healthy volunteers elicits a compartmentalized pulmonary inflammatory response serving as an excellent model to evaluate interventions directed towards suppression of lung inflammation at its earliest stages
In the current single blinded randomized placebo controlled study we are planning to evaluate the effects of inhaled carbon monoxide on local pulmonary inflammatory responses following endotoxin administration Healthy subjects will undergo local endotoxin instillation breathe CO or room air through a mask for 6 hours and then a repeat bronchoscopy with lavage will be done at 6 hours to assess the ability of CO to suppress local inflammation in the lung
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CC-0012 | None | None | None |