Clinical Evaluation Gastrointestinal Motility With PillCam

Gastrointestinal Motility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158989
• Other study ID #: PillCam
• Status: Completed
• Phase: N/A
• First received: July 6, 2010
• Last updated: April 11, 2017
• Start date: May 2006
• Est. completion date: June 2008

Study information

• Verified date: April 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Motility

Intervention

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.

Locations

Country	Name	City	State
United States	University of Louisville Hospital	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	visualization	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	8 hours