Effect of Anesthesia on Force Application During Colonoscopy

Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases Clinical Trial

— CFM  

Official title:

Effect of Anesthesia on Force Application During Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101099
• Other study ID #: CFM-04
• Secondary ID: 5R44DK068936
• Status: Completed
• Phase: N/A
• First received: March 28, 2014
• Last updated: July 11, 2016
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Artann Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Diseases
• Colorectal Neoplasms
• Outpatient Colonoscopy for Colorectal Cancer Screening or for Symptoms Suggestive of Colonic Diseases

Intervention

Device:
• Colonoscopy Force Monitor
Use of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure.

Locations

Country	Name	City	State
United States	Chevy Chase Endoscopy Center	Chevy Chase	Maryland
United States	Univeristy of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Georgetown University Medical Center, Gastroenterology	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Artann Laboratories	Capital Digestive Care, LLC, Georgetown University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak push force is increased in patients receiving propofol as compared to conscious sedation.		6 months	Yes