- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02433444
Computer Aided, Non-invasive, Acoustic Gastrointestinal Surveillance in Post-ERCP Pancreatitis
Computer Aided, Non-invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Post-ERCP Pancreatitis (PEP)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This will be a prospective case series in 100 patients presenting to Cedars Sinai Medical Center who undergo Endoscopic retrograde cholangiopancreatography (ERCP).
The investigators will place the AGIS sensor on each patient enrolled in the study, 30 minutes prior to procedure. The investigators will continuously record AGIS acoustic signals from T-30 minutes to the time that they leave the hospital, either on discharge from the Post-Anesthesia Care Unit or discharge from hospitalization, with the option to discontinue if clinically required or requested by the provider or patient. Acoustic signal will be evaluated, and intestinal motility events will be calculated; however, this data will not be used to make decisions regarding clinical care. Physicians and nurses will not be made aware of the AbStats readings.These measurements are solely observational. Patients will be managed according to standard-of-care practice.
Routinely, patients are kept in the post-operative unit after their procedure, for one hour. Those with pain are examined by a physician and the decision is made to admit for observation to monitor for complications of ERCP, or to discharge home. The patients who are discharged home from procedure will be followed by telephone surveys every day for 2 days post procedure to determine if they have developed symptoms suggestive of PEP. If so, they will be asked to go to the closest urgent care or emergency department for further evaluation. Those who are admitted for observations post procedure will be followed for signs or symptoms of PEP which includes meeting 2 of 3 criteria: Abdominal pain, amylase/lipase >3 times the upper limit of normal 24 hours after procedure, and/or imaging consistent with pancreatitis.
The AGIS multi-sensor wireless abdominal monitoring system includes low profile acoustic sensors that are applied to the anterior abdominal wall with Tegaderm and monitors sounds emanating from the GI tract. The acoustic sensors continuously and non-invasively monitor and capture audio signals representing GI and abdominal wall function. The captured data is recorded in a synchronized manner from two sensors, each placed 3cm on either side of the umbilicus.
After a patient's participation in the study is complete, the investigators will analyze the AbStats readings and the their clinical outcomes to observe if correlations exist between patients with lower intestinal rates and those who develop PEP.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 18 years of age and older
- Patient of Cedars-Sinai Medical Center scheduled for outpatient ERCP to be performed by one of the study investigators/treating physicians
- Able to provide informed consent
Exclusion Criteria:
- Unable to provide consent
- Transfer patients
- Cognitive inability to follow directions to maintain sensors in place
- Unable to place abdominal sensors on patients
- Abdominal cellulitis
- Pregnant women
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
---|---|
Patients receiving ERCP
Patients receiving Endoscopic retrograde cholangiopancreatography (ERCP) at Cedars-Sinai Medical Center.
|
ERCP's performed at Cedars-Sinai Medical Center.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Intestinal Rate
Prazo: Participants will be followed for the duration of their hospital stay, an expected average of 4 days, and for 2 days after hospital discharge.
|
Count of motility events (as measured by AGIS) per minute
|
Participants will be followed for the duration of their hospital stay, an expected average of 4 days, and for 2 days after hospital discharge.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elham Afghani, MD, Cedars-Sinai Medical Center
Publicações e links úteis
Publicações Gerais
- Spiegel BM, Kaneshiro M, Russell MM, Lin A, Patel A, Tashjian VC, Zegarski V, Singh D, Cohen SE, Reid MW, Whitman CB, Talley J, Martinez BM, Kaiser W. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg. 2014 Oct;18(10):1795-803. doi: 10.1007/s11605-014-2597-y. Epub 2014 Aug 5.
- Augustyniak P. Wearable wireless heart rate monitor for continuous long-term variability studies. J Electrocardiol. 2011 Mar-Apr;44(2):195-200. doi: 10.1016/j.jelectrocard.2010.11.014.
- Shambroom JR, Fabregas SE, Johnstone J. Validation of an automated wireless system to monitor sleep in healthy adults. J Sleep Res. 2012 Apr;21(2):221-30. doi: 10.1111/j.1365-2869.2011.00944.x. Epub 2011 Aug 22.
- Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, Overby CS, Aas J, Ryan ME, Bochna GS, Shaw MJ, Snady HW, Erickson RV, Moore JP, Roel JP. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc. 2001 Oct;54(4):425-34. doi: 10.1067/mge.2001.117550.
- Rieger H, Runkel N, Sproder J, Buhr HJ. [Different mechanisms in intestinal paralysis in edematous and necrotizing pancreatitis of the rat]. Langenbecks Arch Chir Suppl Kongressbd. 1998;115(Suppl I):409-12. German.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro00039663
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .