Evaluation of Gastrointestinal Motility With SmartPill

Completed

• Conditions: Gastrointestinal Motility
• Interventions: Device: SmartPill

• Registration Number: NCT01159002
• Lead Sponsor: University of Louisville

Brief Summary

The purpose of this study is to evaluate the clinical usefulness of a capsule (SmartPill\~) measuring pH, pressure and temperature from within the entire GI tract to determine gastric emptying time, combined small and large bowel transit time and total transit time. In addition, the Capsule will characterize pressure patterns and provide motility indices for the antrum and duodenum. It is believed that the condition of your digestive system can have a large impact on your overall physical health. Therefore,the investigators would like to assess whether using the pill device helps to determine any functional problems in patients in the ICU. The investigators are studying ICU patients because any change in their condition can have a large impact on their recovery.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-05
• Study Completion: 2009-01
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• suffered from traumatic or non-traumatic intracranial hemorrhage and were admitted to an intensive care unit (ICU) at University of Louisville Hospital
• sedated and had tracheal intubation and mechanical ventilation
• older than 18 years

Exclusion Criteria

• younger than 18 years
• multiple injuries, especially abdominal trauma or inflammatory bowel disease
• history of complicated abdominal surgery or unknown type of abdominal surgery
• clinical evidence of ileus or suspected bowel obstruction
• a pacemaker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill ICU patients	SmartPill	ICU patients with brain injuries who will be receiving a feeding tube.

Primary Outcome Measures

Name	Time	Method
Transit time	5 days	The subjects were followed from the time of placement of the capsule in the stomach until the capsule was viewed in the stool or abdominal X-rays revealed it had passed from the body

Trial Locations

Locations (1)

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States