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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Need for emergency PEG placement;
International normalized ratio (INR) greater than 1.5;
Platelet count less than 50,000/mm³;
Severe ascites,
Trial population
Elderly ASA IV patients aged 65 years
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial 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.
Locations
Sponsors and contacts
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