Computer Aided, Non-invasive, Acoustic Gastrointestinal Surveillance in Post-ERCP Pancreatitis
Computer Aided, Non-invasive, Acoustic Gastrointestinal Surveillance (AGIS) in Post-ERCP Pancreatitis (PEP)
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patients receiving ERCP
Patients receiving Endoscopic retrograde cholangiopancreatography (ERCP) at Cedars-Sinai Medical Center.
|
ERCP's performed at Cedars-Sinai Medical Center.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intestinal Rate
時間枠: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.
|
協力者と研究者
捜査官
- 主任研究者:Elham Afghani, MD、Cedars-Sinai Medical Center
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
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