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

23 gennaio 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Ritirato

Descrizione dettagliata

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

Tipo di studio

Osservativo

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Inpatients at CSMC

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of acoustic events
Lasso di tempo: One minute
Number of acoustic events recorded by the AbStats device in one minute.
One minute
Mean time to advancement to full diet
Lasso di tempo: Inpatient visit
Mean time to advance a patient to a full diet
Inpatient visit

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Brennan Spiegel, MD, MSHS, Cedars-Sinai Medical Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 giugno 2017

Completamento primario (Anticipato)

1 dicembre 2018

Completamento dello studio (Anticipato)

1 dicembre 2018

Date di iscrizione allo studio

Primo inviato

18 marzo 2015

Primo inviato che soddisfa i criteri di controllo qualità

18 marzo 2015

Primo Inserito (Stima)

24 marzo 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 gennaio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 gennaio 2020

Ultimo verificato

1 gennaio 2020

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • Pro00039256

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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