Effect of Anesthesia on Force Application During Colonoscopy (CFM)

Artann Laboratories

Status: Completed

Conditions: Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases

Treatments: Device: Colonoscopy Force Monitor

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT02101099

5R44DK068936 (U.S. NIH Grant/Contract)

CFM-04

Details and patient eligibility

About

The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). This device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.

Full description

Randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. Twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. An equal number of male and female patients will be included in each group.

Enrollment: 102 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Age: 30-75 years
• ASA Class I or II
• All ethnic and racial groups will be included

Exclusion criteria

• Colonic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor.
• Specific pathology that would limit the extent of examination
• ASA class 3 or greater
• Pregnancy
• Monitored anesthesia using propofol for sedation.
• Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity

Trial design

102 participants in 1 patient group

Patients undergoing colonoscopy

Description:

Patients who are undergoing outpatient colonoscopy for colorectal cancer screening or for symptoms suggestive of colonic diseases.

Treatment:

Device: Colonoscopy Force Monitor