Clinical Evaluation Gastrointestinal Motility With PillCam

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.

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Key information

Conditions

Gastrointestinal Motility

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PillCam video telemetry capsule, Given Imaging Ltd.

Primary outcomes

small bowel transit times

Time frame: 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 outcomes

visualization

Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2008
First posted: Jul 8, 2010
Registry last updated: Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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