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

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ClinicalTrials.gov Identifier: NCT02595788
Recruitment Status : Unknown
Verified November 2015 by Joachim Torp Hoffmann-Petersen, Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : November 3, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Joachim Torp Hoffmann-Petersen, Odense University Hospital

Brief Summary:
Transoesophageal ultrasound examination before and after prone position.

Condition or disease Intervention/treatment
Obesity Spinal Surgery Anaesthesia Changes in Left and Right Ventricle Dimension Changes in Bloodflow Across Cardiac Valves Changes in Dimensions of Inferior Caval Dimension and Hepatic Venous Bloodflow Changes i Myocardial Velocities Changes in Diastolic Function Other: Change from supine to prone position

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Haemodynamic Changes During Anaesthesia in the Prone Position, Evaluated Using Transoesophageal Ultrasound
Study Start Date : March 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Group/Cohort Intervention/treatment
Supine position
Examination in the supine position
Prone position
Change from supine to prone position
Other: Change from supine to prone position
Change from supine to prone position




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Left and rigth ventricle eccentricity index. [ Time Frame: The day of surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for spinal surgery in the prone position. Body mass index above 30.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595788


Contacts
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Contact: Joachim Hoffmann-Petersen, MD +45 40515531 joachimstyrer@yahoo.dk
Contact: Henrik Berg, MD +45 65411060 henrik.berg@rsyd.dk

Locations
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Denmark
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Joachim Hoffmann-Petersen, MD    +45 40515531    joachimstyrer@yahoo.dk   
Contact: Henrik Berg, MD    +45 65411060    henrik.berg@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
Investigators
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Principal Investigator: Joachim Hoffmann-Petersen, MD Specialist Registrar

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Responsible Party: Joachim Torp Hoffmann-Petersen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02595788     History of Changes
Other Study ID Numbers: S-20130032
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs