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AbStats at the Bedside: Improving Patient Feeding Decisions Using an Abdominal Acoustic Score

2020年1月23日 更新者:Brennan Spiegel、Cedars-Sinai Medical Center

This study is being conducted to determine whether providers who have access to their patients' acoustic intestinal rate score as calculated by an abdominal acoustic sensor that continuously monitors bowel sounds (AbStats) will be more likely to advance their patients' diets to a solid diet sooner than those who do not have access to this rate. AbStats calculates intestinal rates by using two small sensors placed on a patient's abdomen to measure and analyze their abdominal sounds.

Patients will be asked to wear a sensor every morning for 20 minutes while they are fasting daily during their inpatient visit. The sensor will measure the sounds within their abdomen. This data will be interpreted by the AbStats device, which will provide an intestinal rate measurement based on the sounds recorded by the sensors.

This intestinal rate will be provided to the patient's treating physician together with other vital signs. The doctor, at his/her discretion, may choose to use this information to make decisions about the patient's feeding status.

調査の概要

状態

引きこもった

条件

介入・治療

詳細な説明

The research team will use an abdominal acoustic sensor that continuously monitors bowel sounds (AbStats) to obtain acoustic measurements from 50 Cedars-Sinai Medical Center (CSMC) hospital patients by placing a disposable sensor on their abdomen. The sensor will be connected to a bedside monitor which records the sounds collected by the sensors and interprets them to create an intestinal rate reading, measured as acoustic events per minute. The research team will enter this score into the patient's chart and make it available to the patient's clinician(s), to use at their discretion to make decisions on whether or not to advance their patient's diet based on intestinal rate interpretation guidelines previously developed. The entry will provide a numerical intestinal rate with a brief interpretation of the score as listed below. This will be based on interpretations of the measures provided by the AbStats bedside computer, which have been previously developed in a wider research study.6 The scores will be interpreted using the following criteria:

Fasting intestinal rate score of <3 per minute: Ileus; Consider holding diet advancement until there is more evidence of GI function (feeding "red light")

Fasting intestinal rate score of 3-5 per minute: Slow motility; Consider advancing to liquid diet if NPO, assuming it is otherwise medically and surgically appropriate (feeding "yellow light")

Fasting intestinal rate score of >5 per minute: Normal motility; consider advancing to full diet if medically and surgically appropriate (feeding "green light")

Even though these readings will be provided in the patient chart, physicians must use their clinical judgment and account for mental status, aspiration risk, medications, surgical and medical comorbidities before making any feeding decisions. The intestinal rate is merely a new piece of information that provides objective evidence of GI function; it is likely superior to current best practices, which are notoriously unreliable for truly determining GI functional status and motility.

The research team will discuss the project with the patient's medical teaching attending physician, and will request their approval prior to approaching a patient. Once the doctor's approval is secured, researchers will approach the patient and provide them with detailed information about the project activities. If they agree to participate, the AbStats sensor will be placed on the patient's abdomen every morning for 20 minutes while the patient is fasting for the duration of their hospital stay. The sensor will be connected to a bedside computer that will process the data and calculate an intestinal rate, which will appear on the AbStats' gateway screen. The rate and its time-stamp will be entered into the patient's CS-Link (CSMC's EHR) chart by the research team. Once the patient is discharged, their participation in the study will be completed.

After discharge, the patient's chart will be reviewed by a member of the research staff. Using the "Dietary Orders" section of the "Active Orders" tab of the "Patient Summary" section of the patients CS-Link chart, we will determine the length of time from fasting (NPO) to full diet for each patient, as X1-X0, where X1 is time of order to full diet and X0 is time of hospital admission as noted in the "Encounters" section of the patient chart. Full diet will be determined from a dietary order in the chart stating "Diet Regular". The time to full diet will be reported in hours.

Medical residents and members of the Cedars-Sinai Department of Health Services Research staff will collect the following data (measures) at the patient's bedside:

Patient time (hours) to advancement to solid diet Abdominal intestinal rate measured by AbStats disposable biosensor

研究の種類

観察的

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Inpatients at CSMC

説明

Inclusion Criteria:

  • Awake and alert
  • Not on a regular diet
  • No mild to moderate acute pancreatitis
  • No obstructed bowel not amenable to feeding tube placement beyond the obstruction
  • No massive GI hemorrhage
  • No impending or established toxic megacolon
  • No colonic perforation
  • No severe dysmotility making enteral feeding not possible
  • No high output intestinal fistula
  • Able to access the gut for enteral feeding
  • No abdominal compartment syndrome
  • No withdrawal of care/DNAR status
  • No evidence of severe or prolonged ileus
  • No hemodynamic compromise (MAP <60) requiring high dose vasopressors alone or in combination with large volume fluid or blood product resuscitation to maintain cellular perfusion
  • No diffuse peritonitis
  • No intractable vomiting
  • Not pregnant
  • At least 18 years of age

Exclusion Criteria:

  • Not awake and alert
  • On regular diet
  • Mild to moderate acute pancreatitis
  • Obstructed bowel not amenable to feeding tube placement beyond the obstruction
  • Massive GI hemorrhage
  • Impending or established toxic megacolon
  • Bowel perforation
  • Severe dysmotility making enteral feeding impossible
  • High output intestinal fistula
  • Unable to access the gut for enteral feeding
  • Abdominal compartment syndrome
  • Withdrawal of care/DNAR status
  • Severe ileus with NG output >1200 ml/d or gastric residual volumes >400 with additional signs of intolerance including absence of bowel sounds, abdominal distention, presence of air/fluid levels on abdominal radiographs
  • Hemodynamic compromise (MAP <60) requiring high dose vasopressors alone or in combination with large volume fluid or blood product resuscitation to maintain cellular perfusion
  • Diffuse peritonitis
  • Intractable vomiting
  • Pregnant women
  • Under 18 years of age

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
Intervention group
Inpatients at CSMC whose abdominal acoustic sounds will be measured using the AbStats device.
Device meant to listen to the sounds of the gut to determine post op ileus.

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
Number of acoustic events
時間枠:One minute
Number of acoustic events recorded by the AbStats device in one minute.
One minute
Mean time to advancement to full diet
時間枠:Inpatient visit
Mean time to advance a patient to a full diet
Inpatient visit

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Brennan Spiegel, MD, MSHS、Cedars-Sinai Medical Center

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2017年6月1日

一次修了 (予想される)

2018年12月1日

研究の完了 (予想される)

2018年12月1日

試験登録日

最初に提出

2015年3月18日

QC基準を満たした最初の提出物

2015年3月18日

最初の投稿 (見積もり)

2015年3月24日

学習記録の更新

投稿された最後の更新 (実際)

2020年1月27日

QC基準を満たした最後の更新が送信されました

2020年1月23日

最終確認日

2020年1月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Pro00039256

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。