Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome

Sedation Problems Clinical Trial

— PACSO  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001792
• Other study ID #: PatPo2012
• Status: Completed
• Phase: N/A
• First received: April 14, 2012
• Last updated: November 13, 2014
• Start date: April 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: November 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• colonoscopy indicated

Exclusion Criteria:

• patient denies sedation

• prior saturation < 90%

• prior heart rate < 50 bpm

• prior blood pressure < 90 mmHg

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breathing Complications
• Sedation Problems

Intervention

Procedure:
• Position the patient during colonoscopy
Position the patient either in a left lateral position during colonoscopy

Device:
• pulse oximeter

Locations

Country	Name	City	State
Germany	Endoscopy Section, Department for Internal Medicine and Gastroenterology, Technical University Munich	Munich	Bavaria
Germany	Krankenhaus Prien	Prien	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of breathing and cardiac problems (decrease of saturation, hypotension, bradycardia) during colonoscopy	saturation and heart rate will be measured continuously, blood pressure will be measures all 3 minutes	participants will be followed for the duration of colonoscopy during hospital stay an expected average of 1 hour	Yes
Secondary	Adenoma detection rate	Adenoma detection rate between the two arms will be compared at the end of the investigation.	1 day	No