Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients

N/ANot Yet RecruitingNCT07758153

Mersin University70 enrolled

Overview

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.

Percutaneous endoscopic gastrostomy is commonly used to provide long-term enteral nutrition in patients who are unable to maintain adequate oral intake. Elderly patients with severe systemic disease and high anesthetic risk may be vulnerable to sedation-related cardiopulmonary adverse events. In some clinical settings, PEG can be performed using topical pharyngeal anesthesia and local anesthesia without systemic sedation. This study will prospectively include elderly ASA IV patients undergoing PEG placement in routine clinical practice. Patients will be categorized into two cohorts according to the sedation strategy used during the procedure: unsedated PEG and sedated PEG. The sedation strategy will not be assigned by the investigators and will be determined according to routine clinical assessment, patient condition, and anesthesiology evaluation when required. The study will compare cardiopulmonary complications within 24 hours, technical success, procedure-related complications, and 30-day clinical outcomes between the two cohorts.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Percutaneous Endoscopic Gastrostomy Enteral Nutrition Feeding Dysphagia

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with indications for percutaneous endoscopic gastrostomy for long-term enteral nutrition. * Patients who have provided written informed consent from the patient or their legally authorized representative. * Those with an Anesthesia Score of ASA 4. Exclusion Criteria: * Need for emergency PEG placement; * International normalized ratio (INR) greater than 1.5; * Platelet count less than 50,000/mm³; * Severe ascites, * Active peritonitis; pregnancy; * Refusal to participate in the study.

Outcomes

Primary Outcomes

Incidence of cardiopulmonary complications within 24 hours after PEG placement

Cardiopulmonary complications will be assessed as a composite outcome including the occurrence of at least one of the following events within the first 24 hours after PEG placement: hypoxemia defined as SpO₂ \<90%, hypotension defined as mean arterial pressure \<65 mmHg, bradycardia defined as heart rate \<50 beats/min, aspiration, need for endotracheal intubation, or intensive care unit admission/transfer.

Time frame: Within 24 hours after PEG placement