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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Clinical Evaluation of SmartPill Capsule for Investigation of Total Intestinal Transit Time and Intestinal Pathology in Critically Ill Patients|
- Transit time [ Time Frame: 5 days ] [ Designated as safety issue: No ]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
|Study Start Date:||November 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Critically ill ICU patients
ICU patients with brain injuries who will be receiving a feeding tube.
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
|United States, Kentucky|
|University of Louisville Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Stefan Rauch, MD||University of Louisville|