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Die klinische Studie NCT06659159 (GLP-1) für Pulmonary Aspiration During Anaesthetic Induction ist noch nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying (GLP-1) 50 Nicht-invasiv Beobachtend
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06659159 (GLP-1) ist eine beobachtungsstudie zur Untersuchung von Pulmonary Aspiration During Anaesthetic Induction und hat den Status noch nicht rekrutierend. Der Start ist für 1. November 2024 geplant, bis 50 Teilnehmer aufgenommen werden. Durchgeführt von Sascha Battig wird der Abschluss für 31. Dezember 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 26. Oktober 2024 aktualisiert.
Kurzbeschreibung
This project explores the elevated risk of pulmonary aspiration during anesthesia in patients undergoing GLP-1 agonist therapy, which prolongs gastric emptying. Despite standard fasting guidelines (6 hours for solids, 2 hours for liquids), some patients still experience aspiration, indicating that GLP-1 therapy may heighten risk. The American Society of Anesthesiologists has advised pausing GLP-1 therapy before surge...Mehr anzeigen
Ausführliche Beschreibung
This project investigates the risk of pulmonary aspiration during anesthesia in patients undergoing treatment with GLP-1 agonists, a class of medications that prolong gastric emptying and are commonly used for obesity and diabetes management. Pulmonary aspiration remains a significant cause of morbidity and mortality in anesthesia-related complications, and patients with delayed gastric emptying are at higher risk. R...Mehr anzeigen
Offizieller Titel
Effects of Beginning a GLP1-Agonist Therapy on Residual Gastric Content and Gastric Emptying: a Prospective Ultrasound Approach with Focus on Perioperative Aspiration Risk.
Erkrankungen
Pulmonary Aspiration During Anaesthetic InductionWeitere Studien-IDs
- GLP-1
- Effects of beginning a GLP1
- Hirslanden Klinik (Andere Zuwendungs-/Finanzierungsnummer) (Hirslanden Klinik, Zurich)
NCT-Nummer
Studienbeginn (tatsächlich)
2024-11-01
Zuletzt aktualisiert
2024-10-26
Studienende (vorauss.)
2026-12-31
Geplante Rekrutierung
50
Studientyp
Beobachtungsstudie
Status
Noch nicht rekrutierend
Stichwörter
Pulmonary aspiration
Gastric ultrasound
GLP-1
Gastroparesis
Gastric ultrasound
GLP-1
Gastroparesis
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
GLP-1, New Therapy Indication, prescription and dosage is determined independently of the study by the endocrinologist/obesity specialist, who is also part of the study team. Since the first gastric ultrasound will take place directly before the initiation of the GLP-1 Agonist therapy, the patients will serve as their own control group/baseline. | Gastrischer Ultraschall The sequence in which the study is conducted will be as follows, the first examination (baseline examination) will take place immediately before the appointment and prescription of GLP-1 Analoga (before the first injection). During the examination the gastric content (quality/quantity) will be determined, secondly, a baseline for gastric emptying time after oral intake of 500ml of water is collected (patient drinks w...Mehr anzeigen |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Gastric content | Sonographic assessment of the gastric content (quality and quantity) after a standardised meal and regular perioperative fasting interval (at least 6 hours for solids and 2 hours for liquids) before initiation and once 6-8 weeks after GLP-1 therapy initiation | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Gastric emptying time | Sonographic measurement of gastric emptying time for 500ml of water before and during GLP-1 therapy. Gastric emptying time is measured with a continuous ultrasound examination. The variable of interest is once again the CSA of the gastric antrum and the time until the baseline from before water consumption is reached once again. | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Number of empty stomachs | Absolute number of empty stomachs after adhering to standardised perioperative fasting intervals (6 hours for solids and 2 hours for liquids) before and once (if therapy is continued: twice) during GLP-1 Agonist therapy | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
BMI | Demographic data of the patient: BMI | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Gallbladder stones | Presence of gallbladder stones (cholecystolithiasis) | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Co-morbidities | Demographic data of the patients: Comorbidities | At the baseline examination at the first endocrinologic appointment |
Side effects GLP-1 | Collection of all side-effects of the GLP-1 therapy | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Discontinuation GLP-1 | Number and reason for discontiuation of GLP-1 therapy | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Co-medication | For gastric emptying relevant co-medications | baseline examination at the first endocrinologic appointment the second examination/data collection will be at the regular endocrinologic control examination 6-8 weeks after therapy initiation. Final examination is 5 months after therapy start |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Beginning a new treatment with GLP-1 Agonists. Indication and prescription determined by an endocrinologist/obesity specialist
- Signed informed consent
- Known pregnancy, known lactation
- Underage (< 18 years)
- Absence of informed consent (missing or inability to provide)
- Anomalies of the gastrointestinal tract
- Known illnesses of the gastrointestinal tract
- Previous surgery of the gastrointestinal tract
- Elevated risk for hypoglycaemia (Sulfonylurea or Insulin)
- No investigator with completed structural education in gastric sonography is available
- Lack of intention to respect the fasting intervals and predefined standardised meals for the sonographic examination
Sascha BattigVerantwortliche Partei
Sascha Battig, Prüfsponsor, Prof. Dr. med. Michael Ganter, Klinik Hirslanden, Zurich
Zentrale Studienkontakte
Kontakt: Michael Ganter Director and Chairman Institute of Anesthesiology and Intensiv, Prof. Dr. med., +41 44 387 38 80, [email protected]
Keine Standortdaten vorhanden