Percutaneous Endoscopic GastrostomyNCT07758153
Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients
An observational study of Percutaneous Endoscopic Gastrostomy and Enteral Nutrition Feeding, run by Mersin University.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Percutaneous Endoscopic Gastrostomy, Enteral Nutrition Feeding, Dysphagia
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly ASA IV patients aged 65 years
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Of Safety And Clinical Outcomes Of Sedated And Unsedated Percutaneous Endoscopic Gastrostomy Procedures İn ASA IV Elderly Patients: A Prospective Observational Cohort Study.
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.
Read the 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.
- Conditions
- Percutaneous Endoscopic Gastrostomy, Enteral Nutrition Feeding, Dysphagia, Elderly Patients (>65 Years)
- Keywords
- Percutaneous endoscopic gastrostomy, Sedation, Unsedated PEG, ASA IV, Cardiopulmonary complications
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours after PEG placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Endoscopic GastrostomyStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilmi Bozkurt, Mersin University
- Investigators
- Hilmi Bozkurt, MD,PhD, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758153
- Sponsor's protocol ID
- PEG study 2026
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Safety And Clinical Outcomes Of Sedated And Unsedated Percutaneous Endoscopic Gastrostomy Procedures İn ASA IV Elderly Patients: A Prospective Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT07758153
- Acronym / sponsor ID
- PEG study 2026
- Conditions
- Percutaneous Endoscopic Gastrostomy, Enteral Nutrition Feeding, Dysphagia, Elderly Patients (>65 Years)
- Keywords
- Percutaneous endoscopic gastrostomy, Sedation, Unsedated PEG, ASA IV, Cardiopulmonary complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly ASA IV patients aged 65 years
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of cardiopulmonary complications within 24 hours after PEG placement
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hilmi Bozkurt, MD,PhD study director
Mersin University
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Endoscopic Gastrostomy and Enteral Nutrition Feeding, run by Mersin University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahsum Barçın, MD (+9005448895064, dr.mahsumbarcin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cardiopulmonary complications within 24 hours after PEG placement (time frame: Within 24 hours after PEG placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.