Haemodynamic Changes During Anaesthesia in the Prone Posi... | NCT02595788

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

NCT02595788

Sponsor

Odense University Hospital

Status

Unknown status

Last Update Posted

Nov 3, 2015Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

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

Interventions

Change from supine to prone position

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Jun 2016Estimated

First Submitted Date

Nov 2, 2015

First Submission Date that Met QC Criteria

Nov 2, 2015

First Posted Date

Nov 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2015

Last Update Posted Date

Nov 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Joachim Torp Hoffmann-Petersen, MD, Odense University HospitalPrincipal Investigator

Lead Sponsor

Odense University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Transoesophageal ultrasound examination before and after 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.

Conditions Module

Conditions

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

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supine position		Examination in the supine position
Prone position		Change from supine to prone position	Other: Change from supine to prone position

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Change from supine to prone position	Other	Change from supine to prone position	Prone position

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joachim Hoffmann-Petersen, MD	Contact	+45 40515531		joachimstyrer@yahoo.dk
Henrik Berg, MD	Contact	+45 65411060		henrik.berg@rsyd.dk

Overall Officials

Name	Affiliation	Role
Joachim Hoffmann-Petersen, MD	Specialist Registrar	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital	Recruiting	Odense		5000	Denmark

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms