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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02595788
Other study ID # S-20130032
Secondary ID
Status Recruiting
Phase N/A
First received November 2, 2015
Last updated November 2, 2015
Start date March 2014
Est. completion date June 2016

Study information

Verified date November 2015
Source Odense University Hospital
Contact Joachim Hoffmann-Petersen, MD
Phone +45 40515531
Email joachimstyrer@yahoo.dk
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial Summary

Transoesophageal ultrasound examination before and after prone position.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Change from supine to prone position
Change from supine to prone position

Locations

Country Name City State
Denmark Odense University Hospital Odense

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary End systolic and diastolic dimension of the left and right ventricle. Studied after induction of anaesthesia, before and after the patient is placed in the prone position. The day of surgery Yes
Secondary Left and rigth ventricle eccentricity index. The day of surgery Yes
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