Clinical Evaluation Gastrointestinal Motility With PillCam

NCT01158989 | Completed

• 1 other identifier: PillCam
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Critical care; Endoscopy, Video Capsule; Nutrition, Enteral

Outcome Measures

Primary Outcomes (1)

• small bowel transit times

  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

  8 hours

Secondary Outcomes (1)

• visualization

  8 hours

Study Arms (2)

Critically ill

Critically ill subjects were intubated, mechanically ventilated and sedated

Device: PillCam

Ambulatory Group

Subjects were scheduled for an outpatient procedure but were otherwise healthy

Device: PillCam

Interventions

PillCam 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.

Also known as: PillCam video telemetry capsule, Given Imaging Ltd.

Ambulatory Group; Critically ill

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Study Officials

• Stefan Rauch, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 8, 2010
• Study Start: May 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2008
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

US (1)