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

• Sponsor: Odense University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02595788
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 27
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Transoesophageal ultrasound examination before and after prone position.

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

• Study Type: Observational
• Anticipated 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: Mar 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. End systolic and diastolic dimension of the left and right ventricle. [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. [The day of surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

• Odense University Hospital

Investigators

• Principal Investigator: Joachim Hoffmann-Petersen, MD, Specialist Registrar

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joachim Torp Hoffmann-Petersen, MD, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT02595788
• Other Study ID Numbers: S-20130032
• First Posted: Nov 3, 2015
• Last Update Posted: Nov 3, 2015
• Last Verified: Nov 1, 2015

Study Results

No Results Posted as of Nov 3, 2015