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

This trial does not accept healthy volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 2 trial groups
Group A: Unsedated PEG
Group B: Sedated PEG

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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