Haemodynamic Changes During Anaesthesia in the Prone Position, Evaluated Using Transoesophageal Ultrasound

November 2, 2015 updated by: Joachim Torp Hoffmann-Petersen, Odense University Hospital
Transoesophageal ultrasound examination before and after prone position.

Study Overview

Detailed Description

Patients undergoing spinal surgery in the prone position are anaesthetized and then an ultrasound probe is placed in the oesophagus and the heart physiology is examined. Following prone position the examination is repeated.

Study Type

Observational

Enrollment (Anticipated)

20

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

      • Odense, Denmark, 5000
        • Recruiting
        • Odense University Hospital
        • Contact:
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for spinal surgery in the prone position. Body mass index above 30.

Description

Inclusion Criteria:

  • adult patients scheduled for spinal surgery in the prone position. Body mass index above 30.

Exclusion Criteria:

  • significant cardiomyopathy or valvular disease
  • heart rhythm other than normal sinus rhythm
  • coagulopathy
  • increased risk of oesophageal injury during probe insertion

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Supine position
Examination in the supine position
Prone position
Change from supine to prone position
Change from supine to prone position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
End systolic and diastolic dimension of the left and right ventricle.
Time Frame: The day of surgery
Studied after induction of anaesthesia, before and after the patient is placed in the prone position.
The day of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Left and rigth ventricle eccentricity index.
Time Frame: The day of surgery
The day of surgery

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Joachim Hoffmann-Petersen, MD, Specialist Registrar

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

March 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (Estimate)

November 3, 2015

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • S-20130032

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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