Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients

NCT07758153 | Not Yet Recruiting

• 1 other identifier: PEG study 2026
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Percutaneous Endoscopic Gastrostomy; Enteral Nutrition Feeding; Dysphagia; Elderly Patients (>65 Years)

Keywords

Percutaneous endoscopic gastrostomy; Sedation; Unsedated PEG; ASA IV; Cardiopulmonary complications

Outcome Measures

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.

  Within 24 hours after PEG placement

Study Arms (2)

Unsedated PEG

Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy with topical pharyngeal anesthesia and local anesthesia, without systemic sedative medication.

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly ASA IV patients aged 65 years

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Hilmi Bozkurt, MD,PhD

  Mersin University

  STUDY DIRECTOR

Central Study Contacts

Mahsum Barçın, MD

CONTACT

+9005448895064; dr.mahsumbarcin@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of General Surgery

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share