Clinical Evaluation Gastrointestinal Motility With PillCam

Completed

• Conditions: Gastrointestinal Motility
• Interventions: Device: PillCam

• Registration Number: NCT01158989
• Lead Sponsor: University of Louisville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Primary Completion: 2007-11
• Study Completion: 2008-06
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ambulatory Group	PillCam	Subjects were scheduled for an outpatient procedure but were otherwise healthy
Critically ill	PillCam	Critically ill subjects were intubated, mechanically ventilated and sedated

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States