Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT01050712
Eligibility Criteria:
Inclusion Criteria:
* Men and women, age \> 18 years.
* Women must be using acceptable contraceptives, post-menopausal or surgically sterile.
* No prior smoking history.
* BMI between 16 and 30 inclusive.
* No significant abnormalities on history, physical examination or laboratory parameters.
Exclusion Criteria:
* Exposure to any carbon monoxide source during the 48 hours prior to the study day or occupational exposure to CO.
* Significant disease or disorder (as explained in Study B).
* Complete bowel obstruction.
* Intra-abdominal inflammation (diverticulitis, inflammatory bowel disease, colitis).
* Retroperitoneal hematomas.
* Known GI motility disorder.
* Underlying lung disease such as pneumonia, asthma or COPD.
* Sepsis.
* Planned pregnancy, already pregnant or breastfeeding.
* Electrolyte disturbance (hypokalemia, hypomagnesemia, hyponatremia).
* Significant opioid and laxative use 4 weeks prior to surgery.
* Anti-inflammatory use 2 days prior to surgery.
* Drugs such as antacids, Coumadin, amitriptyline, chlorpromazine.
* Baseline oxygen saturation \<92% on room air.
* Baseline blood level of COHb \>2%.
* Baseline hemoglobin \<90 g/dL.
* Participation in another clinical trial within 2 months prior to study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01050712
Study Brief:
Protocol Section:
NCT01050712