Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorMersin University

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

Trial groups

70 Participants
are grouped into 2 trial groups

Locations

This trial has no locations

Sponsors and collaborators