Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome

Not Applicable

Completed

• Conditions: Sedation Problems; Breathing Complications

• Registration Number: NCT02001792
• Lead Sponsor: Technical University of Munich

Brief Summary

The purpose of this study is to determine the effects of patient positioning during colonoscopy on patient safety and diagnostic outcome.

Detailed Description

Sedative drugs are widely-used during endoscopic procedures. The administration of these drugs contain the potential hazard of breathing and cardiac complications. Moreover it is well-known that the dorsal position is in some ways associated to breathing problems while patients are asleep. We assume this also to be true related to short anesthesia during colonoscopy. Patient positioning may therefore have a positive effect on the safety during colonoscopy by reducing the absolute time that sedated patients spend in a supine position. We compiled a randomized trial which compares the appearance of breathing and cardiovascular complications by performing colonoscopy either in a dorsal or in a left lateral position.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-14
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-05
• Primary Completion: 2014-02
• Status Verified: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

• colonoscopy indicated

Exclusion Criteria

• patient denies sedation
• prior saturation < 90%
• prior heart rate < 50 bpm
• prior blood pressure < 90 mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
frequency of breathing and cardiac problems (decrease of saturation, hypotension, bradycardia) during colonoscopy	participants will be followed for the duration of colonoscopy during hospital stay an expected average of 1 hour	saturation and heart rate will be measured continuously, blood pressure will be measures all 3 minutes

Secondary Outcome Measures

Name	Time	Method
Adenoma detection rate	1 day	Adenoma detection rate between the two arms will be compared at the end of the investigation.

Trial Locations

Locations (2)

Endoscopy Section, Department for Internal Medicine and Gastroenterology, Technical University Munich; 🇩🇪 Munich, Bavaria, Germany

Krankenhaus Prien; 🇩🇪 Prien, Bavaria, Germany