Clinical Evaluation Gastrointestinal Motility With PillCam - Full Text View

Purpose

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.

Condition	Intervention
Gastrointestinal Motility	Device: PillCam

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Clinical Evaluation of Endoscopic Video Capsule for Investigation of Small Intestine Transit Time and Intestinal Pathology in Critically Ill Patients

Resource links provided by NLM:

MedlinePlus related topics: Critical Care Endoscopy

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	16
Study Start Date:	May 2006
Study Completion Date:	June 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Critically ill Critically ill subjects were intubated, mechanically ventilated and sedated	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.
Ambulatory Group Subjects were scheduled for an outpatient procedure but were otherwise healthy	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.

Groups/Cohorts

Assigned Interventions

Critically ill

Critically ill subjects were intubated, mechanically ventilated and sedated

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.

Ambulatory Group

Subjects were scheduled for an outpatient procedure but were otherwise healthy

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.

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

Critically ill patients (i.e., all were intubated, mechanically ventilated and sedated) and healthy patients scheduled for an outpatient procedure.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158989

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:	NCT01158989 History of Changes
Other Study ID Numbers:	PillCam
Study First Received:	July 6, 2010
Last Updated:	July 7, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Louisville:

Critical care
Endoscopy, Video Capsule
Nutrition, Enteral

ClinicalTrials.gov processed this record on May 21, 2013