Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients
Comparison Of Safety And Clinical Outcomes Of Sedated And Unsedated Percutaneous Endoscopic Gastrostomy Procedures İn ASA IV Elderly Patients: A Prospective Observational Cohort Study.
Study Overview
Status
Detailed Description
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mahsum Barçın, MD
- Phone Number: +9005448895064
- Email: dr.mahsumbarcin@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Unsedated PEG
Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy with topical pharyngeal anesthesia and local anesthesia, without systemic sedative medication.
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Sedated PEG
Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy under sedation as part of routine clinical practice.
Sedative agents may include propofol, midazolam, and/or opioid agents according to clinical and anesthesiology evaluation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of cardiopulmonary complications within 24 hours after PEG placement
Time Frame: Within 24 hours after PEG placement
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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.
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Within 24 hours after PEG placement
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEG study 2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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