Evaluation of Gastrointestinal Motility With SmartPill

This study has been completed.
Sponsor:
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT01159002
First received: July 6, 2010
Last updated: July 7, 2010
Last verified: July 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • 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
Study Population

ICU patients with intracranial hemorrhage

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159002

Locations
United States, Kentucky
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
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 July 24, 2014