Clinical Evaluation Gastrointestinal Motility With PillCam

NCT ID: NCT01158989

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-06-30

Brief 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.

Conditions

Gastrointestinal Motility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Critically ill

Critically ill subjects were intubated, mechanically ventilated and sedated

PillCam

Intervention Type: DEVICE

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.

Ambulatory Group

Subjects were scheduled for an outpatient procedure but were otherwise healthy

PillCam

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

PillCam video telemetry capsule, Given Imaging Ltd.

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan Rauch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville Hospital

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

PillCam

Identifier Type: -

Identifier Source: org_study_id