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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Mahsum Barçın, MD
- Telefonnummer: +9005448895064
- E-post: dr.mahsumbarcin@gmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of cardiopulmonary complications within 24 hours after PEG placement
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Hilmi Bozkurt, MD,PhD, Mersin University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PEG study 2026
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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