ObesityNCT02595788
Haemodynamic Changes During Anaesthesia in the Prone Position, Evaluated Using Transoesophageal Ultrasound
An observational study of Obesity and Spinal Surgery, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Transoesophageal ultrasound examination before and after prone position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Spinal Surgery, Anaesthesia
- What is being tested?
- Change from supine to prone position
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for spinal surgery in the prone position. Body mass index above 30.
Who may be able to join
- adult patients scheduled for spinal surgery in the prone position. Body mass index above 30.
Who cannot join
- significant cardiomyopathy or valvular disease
- heart rhythm other than normal sinus rhythm
- coagulopathy
- increased risk of oesophageal injury during probe insertion
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Joachim Hoffmann-Petersen, MD, +45 40515531, joachimstyrer@yahoo.dk
Henrik Berg, MD, +45 65411060, henrik.berg@rsyd.dk
About this study
Transoesophageal ultrasound examination before and after prone position.
Read the 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
- 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
- Being tested
- Change from supine to prone position
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change from supine to prone positionOther
Change from supine to prone position
| Study group | Role | What they receive |
|---|---|---|
| Supine position | Examination in the supine position | |
| Prone position | Change from supine to prone position Receives: Other: Change from supine to prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The day of surgery
Secondary outcomes (1)
Left and rigth ventricle eccentricity index.
Measured: The day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startMar 2014
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joachim Torp Hoffmann-Petersen, Odense University Hospital
- Investigators
- Joachim Hoffmann-Petersen, MD, Principal investigator, Specialist Registrar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595788
- Sponsor's protocol ID
- S-20130032
- Status last verified
- Nov 2015
- First submitted
- 2 Nov 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamic Changes During Anaesthesia in the Prone Position, Evaluated Using Transoesophageal Ultrasound
- ClinicalTrials.gov ID
- NCT02595788
- Acronym / sponsor ID
- S-20130032
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine position | – | –Examination in the supine position |
| Prone position | – | Other: Change from supine to prone positionChange from supine to prone position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for spinal surgery in the prone position. Body mass index above 30.
Key inclusion criteria (1 listed)
- adult patients scheduled for spinal surgery in the prone position. Body mass index above 30.
Key exclusion criteria (4 listed)
- significant cardiomyopathy or valvular disease
- heart rhythm other than normal sinus rhythm
- coagulopathy
- increased risk of oesophageal injury during probe insertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change from supine to prone positionChange from supine to prone position | Other | Prone position |
Primary outcome
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.
1 secondary outcome
Left and rigth ventricle eccentricity index.
Time frame: The day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Hoffmann-Petersen, MD principal investigator
Specialist Registrar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Spinal Surgery, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joachim Hoffmann-Petersen, MD (+45 40515531, joachimstyrer@yahoo.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
End systolic and diastolic dimension of the left and right ventricle. (time frame: The day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2015.