About this trial
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.
Eligibility criteria
Qualifiers
Patients aged 65 years and older Patients classified as ASA physical status IV Patients with an indication for percutaneous endoscopic gastrostomy for long-term enteral nutrition Patients scheduled to undergo PEG placement in routine clinical practice Written informed consent obtained from the patient or legally authorized representative Availability of clinical, laboratory, procedural, and follow-up data
Disqualifiers
Requirement for emergency PEG placement International normalized ratio greater than 1.5 Platelet count less than 50,000/mm³ Massive ascites Active peritonitis Previous total gastrectomy Pregnancy Refusal to participate in the study
Trial design
Treatments tested in this trial
- Not listed