Evaluation of Gastrointestinal Motility With SmartPill
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastrointestinal Motility |
Device: SmartPill |
| Study Type: | Observational |
| 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
| Enrollment: | 8 |
| Study Start Date: | November 2007 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Critically ill ICU patients
ICU patients with brain injuries who will be receiving a feeding tube.
|
Device: SmartPill
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
ICU patients with intracranial hemorrhage
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
Contacts and Locations| United States, Kentucky | |
| University of Louisville Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| Principal Investigator: | Stefan Rauch, MD | University of Louisville |
More Information
No publications provided
| Responsible Party: | Stefan Rauch, University of Louisville |
| ClinicalTrials.gov Identifier: | NCT01159002 History of Changes |
| Other Study ID Numbers: | SmartPill |
| Study First Received: | July 6, 2010 |
| Last Updated: | July 7, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Louisville:
|
Endoscopy, Video Capsule Motility, Gastrointestinal |
ClinicalTrials.gov processed this record on June 17, 2013