Which is safer for frail seniors: sedation or no sedation during feeding tube placement?
NCT ID NCT07758153
First seen Aug 11, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study looks at whether using sedation during a feeding tube procedure (percutaneous endoscopic gastrostomy, or PEG) is safer than not using it in elderly patients who are very ill (classified as ASA IV). The main focus is on heart and lung complications within the first 24 hours after the procedure. Researchers will also track technical success, procedure time, hospital stay, and outcomes like mortality and readmission within 30 days. The findings could help doctors choose the best approach for this vulnerable group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sedation (or no sedation) during percutaneous endoscopic gastrostomy (PEG) placement
- What this could lead to
- If one approach proves safer, it could guide how feeding tubes are placed in frail older adults, reducing complications and improving recovery.
- What could go wrong
- This is an observational study, so it can't prove cause and effect. Results may be influenced by patient differences, and the small size limits generalizability.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Elderly ASA IV patients aged 65 years
- Ages
-
65 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Asa physical status iv are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a gentle ear zap teach babies to swallow?
- Smart tongue trainer aims to restore swallowing after stroke
- Brain stimulation may boost swallowing recovery after stroke
- A bedside ultrasound could reveal hidden swallowing risks in the ICU
- A gentle vibration could prompt safer swallowing in Parkinson's
- Can gentle air puffs to the throat reboot swallowing after stroke?