Evaluation of Gastrointestinal Motility With SmartPill

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastrointestinal Motility

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Transit time

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Clinical Evaluation of SmartPill Capsule for Investigation of Total Intestinal Transit Time and Intestinal Pathology in Critically Ill Patients

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Jul 8, 2010
Registry last updated: Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed