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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02065583
Other study ID # Spiegel 0016
Secondary ID
Status Recruiting
Phase N/A
First received December 20, 2013
Last updated December 9, 2015
Start date December 2013
Est. completion date January 2018

Study information

Verified date December 2015
Source VA Greater Los Angeles Healthcare System
Contact Jennifer Talley, MSPH
Phone 310-423-0508
Email Jennifer.Soares@cshs.org
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Observational

Clinical Trial Summary

This study will measure the accuracy of a disposable, non-invasive device for the continuous monitoring of abdominal sounds, called the AGIS sensor (Acoustic Gastro-Intestinal Surveillance) in predicting patients' intolerance to feeding (defined as severe nausea, vomiting, or need to place a nasogastric tube within 4 hours of initiating a standard feeding protocol) following abdominal surgery. This will be a pragmatic, observational study.


Description:

Using advances in low-cost sensor technologies and computer-aided analysis, the investigators have developed a disposable, non-invasive device for the continuous monitoring of abdominal sounds, called an AGIS sensor (Acoustic Gastro-Intestinal Surveillance). Following abdominal surgery, the standard protocol employed by most hospitals is to feed patients on their first post-operative day. However, one in every four patients is unable to tolerate feeding because of delayed recovery of bowel function, a condition called post-operative ileus (POI). Following abdominal surgery, monitoring for POI is typically limited to incidental interactions with the attending physician or other staff, which occur only intermittently throughout the day. The AGIS system specifically addresses postoperative digestion monitoring by offering continuous analysis of GI signals, automated processing of the signals, and immediate reporting of the patient's progress to caretakers.

The AGIS system is a compact, rapidly deployable unit that is comfortable for subjects and convenient in application. The AGIS sensor includes a standard microelectronic microphone for measurement of abdominal vibration and acoustic signals. The material in contact with the subject is standard 3M Tegaderm wound bandage adhesive material which is disposable, avoiding the need for cleaning and disinfection.

The AGIS sensor includes fine, flexible and convenient cables that connect to the AGIS Gateway, a low voltage battery powered device with a size approximately of a smartphone. The AGIS Gateway monitors the AGIS sensor signals and provides a measurement of intestinal motility and reports an AGIS Feeding Index score. The score is calculated using the number of acoustic events detected by AGIS per minute.

The investigators recently performed a proof-of-concept, cross-sectional study to test whether the AGIS monitoring system could distinguish healthy control participants from patients recovering from GI surgery. Seven healthy control participants were fed a breakfast and monitored with AGIS for two hours following the meal, allowing the investigators to obtain acoustic data and calculate a normal range of AGIS scores. The investigators also placed the sensor on patients recovering from abdominal surgery. The investigators monitored each patient for two hours and compared their AGIS scores to those of healthy controls using ANOVA with post-hoc comparisons. AGIS successfully discriminated among healthy control, patients tolerating food, and patients with POI.

Although the investigators' pilot data indicate that AGIS can distinguish patients from healthy controls, and can further distinguish between patients with POI vs. those tolerating food, the investigators do not yet know if AGIS can reliably predict which patients will fail to tolerate postoperative feeding. The investigators propose to test the predictive validity of the AGIS system in a pragmatic, observational study of patients scheduled for abdominal surgery.

Hypothesis: Using AGIS signals recorded on the day of abdominal surgery, AGIS can predict which patients will fail to tolerate postoperative feeding vs. which can be safely fed; AGIS will achieve an overall accuracy of 80% or greater.

Study Design: The investigators will place the AGIS sensor on GI patients for 20 minutes during the immediate pre-operative phase to establish a baseline AGIS motility rate. Following abdominal surgery, the surgeons will place the AGIS sensor on the patient in the operating room, and will begin recording for 60 minutes as the patients is transferred and recovers in the post-anesthesia care unit. AGIS recordings will be collected continuously throughout the remaining of the patient's hospital stay. As this is an observational study, physicians and nurses will not be made aware of the AGIS readings. Patients will be managed according to standard practice. The investigators' goal will be to determine the accuracy of AGIS in predicting post-operative feeding tolerance in the context of usual care and without the "Hawthorne effect" potentially impacting care decisions. Investigators blinded to the AGIS recordings will abstract all data and outcomes.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. 18 years of age or older

2. Patient scheduled to undergo abdominal surgery

Exclusion Criteria:

1. Cannot consent or has no surrogate who can consent.

2. Cognitive inability to follow directions to maintain abdominal device in place

3. Any abdominal wall condition that disallows topical coverage as deemed by the managing surgeons (e.g. open abdominal wound, oozing wound, advanced cellulitis, necrotizing fasciitis, etc)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
VA Greater Los Angeles Healthcare System Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Count of motility events per minute. The primary unit of analysis will be the number of motility events registered by the AGIS sensor per minute. 1 minute No
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