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Clinical Evaluation Gastrointestinal Motility With PillCam

This study has been completed.
Sponsor:
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT01158989
First received: July 6, 2010
Last updated: July 7, 2010
Last verified: July 2010
History of Changes

July 6, 2010
July 7, 2010
May 2006
November 2007   (final data collection date for primary outcome measure)
small bowel transit times [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Small bowel transit time was calculated by measuring the difference between the start-time (i.e., placement of the capsule in the duodenum) and end-time (i.e., capsule enters the cecum). Examination of the differences between subsequent images indicates the amount of capsule movement and is proportional to the instant velocity ("motility") of the capsule
Same as current
Complete list of historical versions of study NCT01158989 on ClinicalTrials.gov Archive Site
visualization [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
The quality of the visualization was determined using a three-step scale: Grade 0: intraluminal fluid disturbed visualization and significantly impaired interpretation: grade 1: intraluminal fluid present but did not impair visualization or interpretation; grade 2: no intraluminal fluid, excellent visualization
Same as current
Not Provided
Not Provided
 
Clinical Evaluation Gastrointestinal Motility With PillCam
Clinical Evaluation of Endoscopic Video Capsule for Investigation of Small Intestine Transit Time and Intestinal Pathology in Critically Ill Patients

The purpose of this study is to evaluate the clinical usefulness of a video camera pill (PillCam) in assessing intestinal function in the small intestines of patients. It is believed that the condition of the subjects digestive system can have a large impact on their 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. The same device will be used in healthy subjects scheduled for elective ambulatory surgery.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Critically ill patients (i.e., all were intubated, mechanically ventilated and sedated) and healthy patients scheduled for an outpatient procedure.
Gastrointestinal Motility
Device: PillCam
Within four days of hospital admission, qualifying critically ill patients were assigned to the study and received a gastro-jejunal tube and one PillCam video telemetry capsule (Given Imaging Ltd., Yoqneam, Israel). In each critical care patient, placement of the video capsule was coupled with the placement of the medically necessary feeding tube. A flexible endoscope was inserted into the patient's mouth, and then advanced into the esophagus, stomach, and upper small intestine. The capsule was placed into a capsule delivery device and released into the distal duodenum after it had passed beyond the sight of the scope; a wire was placed to facilitate passage of the feeding tube. An abdominal X-ray was obtained to confirm feeding tube tip placement.
Other Name: PillCam video telemetry capsule, Given Imaging Ltd.
  • Critically ill
    Critically ill subjects were intubated, mechanically ventilated and sedated
    Intervention: Device: PillCam
  • Ambulatory Group
    Subjects were scheduled for an outpatient procedure but were otherwise healthy
    Intervention: Device: PillCam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
June 2008
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • mild-to-moderate brain injury patients who suffered from traumatic or non-traumatic intracranial hemorrhage
  • admitted to an intensive care unit (ICU)
  • needed an enteral tube placed for feeding
  • control (ambulatory) group consisted of outpatients with no history of major abdominal surgery

Exclusion Criteria:

  • younger than 18 years
  • suffered multiple injuries (especially abdominal trauma or inflammatory bowel disease)
  • had a history of complicated or unknown abdominal surgery
  • presented with clinical evidence of ileus or suspected obstruction
  • Patients with a pacemaker
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01158989
PillCam
No
Stefan Rauch, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Stefan Rauch, MD University of Louisville
University of Louisville
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP