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 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT03461328
Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing cancer larynx surgery (partial laryngectomy, total laryngectomy with or without neck dissection).
* Age more than 40 years old
* ASA physical status II and III.
* Diagnosed as having COPD by preoperative spirometry. The classification is bases on the post-bronchodilators forced expiratory volume in the first second (FEV1). Mild COPD is diagnosed when FEV1 is \> 80% of predicted while moderate COPD is diagnosed when FEV1 is \< 80% and \> 50% of predicted and sever COPD is diagnosed when FEV1 is \< 50% and \> 30% of predicted
Exclusion Criteria:
* o Patients with heart failure.
* History with arrhythmias or treatment with antiarrhythmic drugs.
* Patient with heart block or on beta blockers or calcium channel blockers.
* Patients with impaired renal function (creatinine \> 2)
* Patients with impaired liver function (ALT more than 2 folds).
* Patient with combined restrictive and obstructive pulmonary disease.
* Patients with preoperative tracheostomy.
* Patients with huge mass obstructing \> 50% of the view. (due to its influence on the spirometry measurements).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03461328
Study Brief:
Protocol Section:
NCT03461328