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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02595788
• Other study ID #: S-20130032
• 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

• Anaesthesia
• Changes i Myocardial Velocities
• Changes in Bloodflow Across Cardiac Valves
• Changes in Diastolic Function
• Changes in Dimensions of Inferior Caval Dimension and Hepatic Venous Bloodflow
• Changes in Left and Right Ventricle Dimension
• Obesity
• Spinal Surgery

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