Clinical Evaluation Gastrointestinal Motility With PillCam

NCT01158989 — Completed, 16 participants, University of Louisville

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Clinical Evaluation of Endoscopic Video Capsule for Investigation of Small Intestine Transit Time and Intestinal Pathology in Critically Ill Patients

Registry	NCT01158989
Status	Completed
Study type	Observational
Enrollment	16 (Actual)
Sponsor	University of Louisville (Other)
Conditions	Gastrointestinal Motility
Interventions	PillCam (Device)
Dates	start 2006-05-01, primary completion 2007-11-01, completion 2008-06-01, first posted 2010-07-08, last updated 2017-04-13
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Critically ill		Device: PillCam	Critically ill subjects were intubated, mechanically ventilated and sedated
Ambulatory Group		Device: PillCam	Subjects were scheduled for an outpatient procedure but were otherwise healthy

PillCam (Device), also known as PillCam video telemetry capsule, Given Imaging Ltd.: 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.

+Outcome measures

Primary outcomes

small bowel transit times [8 hours]: 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

Secondary outcomes

visualization [8 hours]: 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

+Eligibility

Sex: All, ages: 18 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
University of Louisville Hospital	Louisville, Kentucky	United States

+Investigators

Stefan Rauch, MD, Principal investigator, University of Louisville