Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome (PACSO)

November 13, 2014 updated by: Technical University of Munich
The purpose of this study is to determine the effects of patient positioning during colonoscopy on patient safety and diagnostic outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

412

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Endoscopy Section, Department for Internal Medicine and Gastroenterology, Technical University Munich
      • Prien, Bavaria, Germany
        • Krankenhaus Prien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • colonoscopy indicated

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Controll group
Patients lying in a supine position during colonoscopy
Device: pulse oximeter
Active Comparator: Intervention
Patients lying in a left lateral position during colonoscopy
Device: pulse oximeter
Procedure: Position the patient during colonoscopy
Position the patient either in a left lateral position during colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be followed for the duration of colonoscopy during hospital stay an expected average of 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: 1 day
Adenoma detection rate between the two arms will be compared at the end of the investigation.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Peter Klare, MD, Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany
  • Study Director: Stefan von Delius, PD MD, Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 14, 2012

First Submitted That Met QC Criteria

December 4, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PatPo2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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