MedDataX Logo

Patient Positioning During Colonoscopy: Effects on Safety and Diagnostic Outcome

NCT ID: NCT02001792

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Sedation Problems Breathing Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Controll group

Patients lying in a supine position during colonoscopy

Group Type SHAM_COMPARATOR

pulse oximeter

Intervention Type DEVICE

Intervention

Patients lying in a left lateral position during colonoscopy

Group Type ACTIVE_COMPARATOR

Position the patient during colonoscopy

Intervention Type PROCEDURE

Position the patient either in a left lateral position during colonoscopy

pulse oximeter

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Position the patient during colonoscopy

Position the patient either in a left lateral position during colonoscopy

Intervention Type PROCEDURE

pulse oximeter

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* colonoscopy indicated

Exclusion Criteria

* patient denies sedation
* prior saturation \< 90%
* prior heart rate \< 50 bpm
* prior blood pressure \< 90 mmHg
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Klare, MD

Role: PRINCIPAL_INVESTIGATOR

Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany

Stefan von Delius, PD MD

Role: STUDY_DIRECTOR

Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Munich, Bavaria, Germany

Site Status

Krankenhaus Prien

Prien am Chiemsee, Bavaria, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26126161 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PatPo2012

Identifier Type: -

Identifier Source: org_study_id