Evaluation of Gastrointestinal Motility With SmartPill

NCT01159002 | Completed

• 1 other identifier: SmartPill
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Motility

Keywords

Endoscopy, Video Capsule; Motility, Gastrointestinal

Outcome Measures

Primary Outcomes (1)

• Transit time

  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

  5 days

Study Arms (1)

Critically ill ICU patients

ICU patients with brain injuries who will be receiving a feeding tube.

Device: SmartPill

Interventions

SmartPill DEVICE

Qualifying patients were assigned to the study within four days of hospital admission. They all received a gastro-duodenal tube and capsule. The motility capsule (SmartPill®) was placed into the capsule delivery device (AdvanCE™, US Endoscopy) and advanced blindly into the stomach and released

Critically ill ICU patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients with intracranial hemorrhage

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Study Officials

• Stefan Rauch, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 8, 2010
• Study Start: November 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: January 1, 2009
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)