Clinical Trial

Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients

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Summary
This prospective observational cohort study aims to compare the safety and clinical outcomes of sedated and unsedated percutaneous endoscopic gastrostomy procedures in elderly patients classified as ASA IV. The primary outcome is the development of cardiopulmonary complications within the first 24 hours after the procedure. Secondary outcomes include technical success, procedure duration, early procedure-related complications, length of hospital stay, intensive care requirement, 30-day mortality, and 30-day readmission.
Trial Details
NCT Number NCT07758153
Lead Sponsor Mersin University
Conditions Percutaneous Endoscopic Gastrostomy, Enteral Nutrition Feeding, Dysphagia, Elderly Patients (>65 Years), ASA Physical Status IV
Enrollment 70 participants
Start Date 2026-07-15
Primary Completion 2027-06 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-11