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Completed

NCT Number: NCT02001792

Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • colonoscopy indicated

Exclusion criteria

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

Treatment and study plan

Position the patient during colonoscopy

Procedure

Position the patient either in a left lateral position during colonoscopy

Pulse Oximeter

Device

Primary outcomes

  1. frequency of breathing and cardiac problems (decrease of saturation, hypotension, bradycardia) during colonoscopy

    Time frame: 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 outcomes

  1. Adenoma detection rate

    Time frame: 1 day

    Adenoma detection rate between the two arms will be compared at the end of the investigation.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Acronym: PACSO

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2013
Registry last updated
Nov 14, 2014

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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