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:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-24 @ 7:22 PM
NCT ID:
NCT06282003
Eligibility Criteria:
Inclusion Criteria:
* the inclusion criteria were as follows:
* subject status according to the American Society of Anesthesiologists Association classification
* ASA 1 (normal healthy patients, i.e. patients without associated comorbidities) or ASA 2 (patients with mild systemic disease, such as well-controlled hypertension), normal heart and lung function, both sexes,
* non-smokers, normal X-ray findings for heart and lungs,
* age 18-65 years,
* planned operation of medial laparotomy for colorectal cancer with a minimum duration of anesthesia of at least one hour,
* signed informed consent.
* In the case of hypertension in ASA 2 patients enrolled in the study, by examining the self-monitoring diary for the past three months (as described in Gropper et al., 2019), there was no increase in systolic pressure more than 20 mmHg from the average daily value and no increase in diastolic arterial pressure more than 10 mmHg from the average daily value.
* In the case of diabetes type II in ASA 2 patients enrolled in the study, the HbA1c values were not higher than 7% while taking oral hypoglycemic drugs and having a regulated diet. The patients enrolled also had no complications or episodes of hypoglycemia in the past three months, as described by Gropper et al., 2019.
* In the case of thyroid disease in ASA 2 patients enrolled in the study, values of TSH, fT3, and fT4 in the period up to 6 months since the last examination were normal.
Exclusion Criteria:
* ASA 4 status
* terminal renal illness
* cardiac status NYHA III i NYHA IV
* at home oxygenotherapy during 16 hours
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06282003
Study Brief:
Protocol Section:
NCT06282003