Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome

Study Overview
=================
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.

Conditions
-----------------
Sedation Problems, Breathing Complications

Intervention / Treatment
-----------------
* Procedure: Position the patient during colonoscopy
* Device: pulse oximeter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colonoscopy indicated Exclusion Criteria: patient denies sedation prior saturation < 90% prior heart rate < 50 bpm prior blood pressure < 90 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedation, endoscopy, patient positioning, hypoxemia