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:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT01470534
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 yrs
* Correct BMI and waist circumference criteria : Obese group - BMI ≥30 AND waist circumference ≥94 cm in men and ≥ 80 cm in women, Non obese group - BMI 18.5-25 AND waist circumference ≤94cm in men and ≤80 cm in women Due to undergo elective major abdominal surgery ASA I-III Caucasian patients Able to give informed consent and comply with study protocol
Exclusion Criteria:
* History of significant preoperative weight loss (\>10% over preceding 3 weeks)
* Clinical history of pulmonary aspiration
* Known gastro-oesophageal reflux disease (GORD) or hiatus hernia
* History of difficult intubation or conditions leading to the latter such as: previous neck radiotherapy/rheumatoid arthritis/presence of thyroid goitre
* Metabolic disorders (e.g. diabetes mellitus, thyroid disease, Cushing's Syndrome)
* Simultaneous participation in another clinical study or involvement in a clinical study within the preceding 3 months,
* Patients with suspicion of alcohol/drug abuse
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01470534
Study Brief:
Protocol Section:
NCT01470534