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Clinica MayoEffect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists 150
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La sperimentazione clinica NCT07006142 è uno studio interventistico per Upper Endoscopy, GLP1-R-related Disease, attualmente in arruolamento. Avviato il 1 agosto 2025, prevede di arruolare 150 partecipanti. Sotto la guida di la Clinica Mayo, dovrebbe concludersi entro il 30 aprile 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 3 febbraio 2026.
Sommario breve
The aim of this study is to determine whether a modified fasting protocol can reduce the potential risk of aspiration for patients currently prescribed GLP1-RAs.
Descrizione dettagliata
The overall objective of this project is to identify a reasonable means by which patients on GLP1-RAs can be safely cared for in the perioperative period that can be agreed upon by all groups involved in perioperative patient care. This will be assessed in patients undergoing upper endoscopy specifically since assessment of gastric contents would be minimally invasive for this patient population receiving anesthetic ...Mostra di più
Titolo ufficiale
Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
Patologie
Upper EndoscopyGLP1-R-related DiseaseAltri ID dello studio
- 23-013192
Numero NCT
Data di inizio (effettiva)
2025-08-01
Ultimo aggiornamento pubblicato
2026-02-03
Data di completamento (stimata)
2026-04-30
Arruolamento (previsto)
150
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
GLP1 receptor agonists
upper endoscopy
upper endoscopy
Scopo principale
Prevenzione
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Nessun interventoNormal fasting guidelines and not taking GLP1-RAs Patients who are not taking GLP1 RAs (Receptor Agonists) and who will abide by the normal fasting guidelines | N.D. |
Nessun interventoNormal fasting guidelines with GLP1-RAs Patients who are taking GLP1 RAs (Receptor Agonists) for either diabetes or weight loss management who will abide by normal fasting guidelines | N.D. |
SperimentaleModified fasting guidelines with GLP1-RAs Patients who are prescribed and taking GLP1 RAs (Receptor Agonists) for either diabetes or weight loss management who follow the modified fasting guidelines. Modified fasting consists of a full-liquid diet 48 hours prior to the procedures, clear liquid diet 24 hours prior to their procedure, and nothing by mouth (NPO) after midnight on the day of their procedure. | Modified Fasting Guidelines Patients will follow a full-liquid diet 48 hours prior to their procedure, clear liquid diet 24 hours prior to their procedure, and nothing by mouth (NPO) after midnight on the day of their procedure |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Gastric contents | Number of patients who were found to have gastric contents within the stomach during the upper endoscopy. | Baseline |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Diagnosis of aspiration within 72 hours of procedure | Whether or not a patient was diagnosed with aspiration will be determined via chart review for 72 hours after the completion of upper endoscopy. A note documenting aspiration or an ICD code associated with aspiration will indicate that this outcome occurred. | From the time of upper endoscopy until 72 hours post-procedure. |
Aspiration pneumonitis diagnosis postoperatively | The number of patients who have a diagnosis of aspiration pneumonitis, as identified by the presence of ICD codes J69.0 or J69.8, postoperatively. | 72 hours after completion of upper endoscopy |
Postprocedural ICU admission | The number of patients who were admitted to the ICU immediately after upper endoscopy. | Immediately after upper endoscopy |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Patients undergoing elective upper endoscopy with gastroenterology team
- Urgent or emergent procedure
- Inclusion of colonoscopy or antegrade small bowel enteroscopy in planned procedure
- Upper GI barium study performed in past 24 hours.
- Gastroparesis
- Achalasia
- Pancreatitis
- Use of outpatient pro-motility medications
- Patient refusal
- Inability for patient to provide own consent
Clinica Mayo861 studi clinici attivi da esplorareParte responsabile dello studio
Krishnan Ramanujan, Investigatore principale, Principal Investigator, Mayo Clinic
Contatti principali dello studio
Contatto: Krishnan Ramanujan, MD, 507-422-4898, [email protected]
1 Centri dello studio in 1 paesi
Minnesota
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Krishnan Ramanujan, MD, Contatto, 507-422-4898, [email protected]
In arruolamento