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Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists 150

Em recrutamento
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07006142 é um estudo intervencionista para Upper Endoscopy, GLP1-R-related Disease. Seu status atual é: em recrutamento. O estudo começou em 1 de agosto de 2025 e pretende incluir 150 participantes. Coordenado por a Clínica Maio e deve ser concluído em 30 de abril de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 3 de fevereiro de 2026.
Resumo
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.
Descrição detalhada
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 ...Mostrar mais
Título oficial

Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists

Condições médicas
Upper EndoscopyGLP1-R-related Disease
Outros IDs do estudo
  • 23-013192
Número NCT
Data de início (real)
2025-08-01
Última atualização postada
2026-02-03
Data de conclusão (estimada)
2026-04-30
Inscrição (estimada)
150
Tipo de estudo
Intervencionista
FASE
N/A
Status
Em recrutamento
Palavras-chave
GLP1 receptor agonists
upper endoscopy
Propósito principal
Prevenção
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
Nenhuma intervençãoNormal 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/A
Nenhuma intervençãoNormal 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/A
ExperimentalModified 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
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Gastric contents
Number of patients who were found to have gastric contents within the stomach during the upper endoscopy.
Baseline
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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 de participação
Critérios de elegibilidade

Idades elegíveis
Adulto, Idoso
Idade mínima
18 Years
Sexos elegíveis
Todos
  • 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
Responsável pelo estudo
Krishnan Ramanujan, Investigador principal, Principal Investigator, Mayo Clinic
Contato central do estudo
Contato: Krishnan Ramanujan, MD, 507-422-4898, [email protected]
1 Locais do estudo em 1 países

Minnesota

Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States
Krishnan Ramanujan, MD, Contato, 507-422-4898, [email protected]
Em recrutamento