- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02595788
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
Status
Unknown
Conditions
Intervention / Treatment
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:
- Joachim Hoffmann-Petersen, MD
- Phone Number: +45 40515531
- Email: joachimstyrer@yahoo.dk
-
Contact:
- Henrik Berg, MD
- Phone Number: +45 65411060
- Email: henrik.berg@rsyd.dk
-
-
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.
Sponsor
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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