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

Primary Purpose

Sedation Problems, Breathing Complications

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Position the patient during colonoscopy
pulse oximeter
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sedation Problems focused on measuring sedation, endoscopy, patient positioning, hypoxemia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • colonoscopy indicated

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Controll group

Intervention

Arm Description

Patients lying in a supine position during colonoscopy

Patients lying in a left lateral position during colonoscopy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 14, 2012
Last Updated
November 13, 2014
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02001792
Brief Title
Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome
Acronym
PACSO
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedation Problems, Breathing Complications
Keywords
sedation, endoscopy, patient positioning, hypoxemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
412 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controll group
Arm Type
Sham Comparator
Arm Description
Patients lying in a supine position during colonoscopy
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Patients lying in a left lateral position during colonoscopy
Intervention Type
Procedure
Intervention Name(s)
Position the patient during colonoscopy
Intervention Description
Position the patient either in a left lateral position during colonoscopy
Intervention Type
Device
Intervention Name(s)
pulse oximeter
Primary Outcome Measure Information:
Title
frequency of breathing and cardiac problems (decrease of saturation, hypotension, bradycardia) during colonoscopy
Description
saturation and heart rate will be measured continuously, blood pressure will be measures all 3 minutes
Time Frame
participants will be followed for the duration of colonoscopy during hospital stay an expected average of 1 hour
Secondary Outcome Measure Information:
Title
Adenoma detection rate
Description
Adenoma detection rate between the two arms will be compared at the end of the investigation.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: colonoscopy indicated Exclusion Criteria: patient denies sedation prior saturation < 90% prior heart rate < 50 bpm prior blood pressure < 90 mmHg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Klare, MD
Organizational Affiliation
Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan von Delius, PD MD
Organizational Affiliation
Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Endoscopy Section, Department for Internal Medicine and Gastroenterology, Technical University Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany
Facility Name
Krankenhaus Prien
City
Prien
State/Province
Bavaria
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26126161
Citation
Klare P, Huth R, Haller B, Huth M, Weber A, Schlag C, Reindl W, Schmid RM, von Delius S. Patient position and hypoxemia during propofol sedation for colonoscopy: a randomized trial. Endoscopy. 2015 Dec;47(12):1159-66. doi: 10.1055/s-0034-1392329. Epub 2015 Jun 30.
Results Reference
derived

Learn more about this trial

Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome

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