Hemodynamic Variation During SurgeryNCT01957605
Mean Systemic Pressure Measurement During Prone Position Surgery
An observational study of Hemodynamic Variation During Surgery, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Venous return is driven by the pressure gradient between mean systemic pressure and right atrial pressure. However, mean systemic pressure is more a physiological concept than an available clinical measurement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Variation During Surgery
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Oct 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: Patient scheduled for neurosurgery in the prone position
Who may be able to join
- Prone position neurosurgery
- High-risk neurosurgery
Who cannot join
- Emergency surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Strasbourg
Strasbourg, 67091
Julien Pottecher, MD
About this study
Official title: Study of Hemodynamic Variations During Prone Position Surgery: Measurement of Mean Systemic Pressure and Venous Return Resistance
Venous return is driven by the pressure gradient between mean systemic pressure and right atrial pressure. However, mean systemic pressure is more a physiological concept than an available clinical measurement. Indeed, the mean systemic pressure is the one that would be measured anywhere within the vascular system after cardiac arrest. Recent advances in hemodynamic monitoring have made MSP available to the clinician through beat-by-beat cardiac output measurements during respiratory pauses under mechanical ventilation. In this way, it is possible to calculate MSP, the pressure gradient and the venous return resistances. The investigators aim is to explain the hemodynamic variations and the decrease in cardiac output observed during prone position. The investigators hypothesis is that venous return resistances are increased during prone position probably following an increased intra-abdominal pressure.
- Conditions
- Hemodynamic Variation During Surgery
- Keywords
- prone position, hemodynamic variation, mean systemic pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| prone position | Patient scheduled for surgery in the prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean systemic pressure variation
change of mean systemic pressure from supine position to prone position during surgery
Measured: during surgery after the patient is put in prone position
Secondary outcomes (2)
intrathoracic pressure variation
Change of intrathoracic pressure from supine position to prone position during surgery
Measured: during surgery during surgery after the patient is put in prone position
intravesical pressure variation
Change of intravesical pressure from supine position to prone position during surgery
Measured: during surgery during surgery after the patient is put in prone position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic Variation During SurgeryStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Pottecher, MD, Principal investigator, University Hospital of Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957605
- Sponsor's protocol ID
- 5673
- Status last verified
- Sep 2015
- First submitted
- 1 Oct 2013
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hemodynamic Variations During Prone Position Surgery: Measurement of Mean Systemic Pressure and Venous Return Resistance
- ClinicalTrials.gov ID
- NCT01957605
- Acronym / sponsor ID
- 5673
- Conditions
- Hemodynamic Variation During Surgery
- Keywords
- prone position, hemodynamic variation, mean systemic pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 8 Oct 2013 (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.
Venous return is driven by the pressure gradient between mean systemic pressure and right atrial pressure. However, mean systemic pressure is more a physiological concept than an available clinical measurement. Indeed, the mean systemic pressure is the one that would be measured anywhere within the vascular system after cardiac arrest. Recent advances in hemodynamic monitoring have made MSP available to the clinician through beat-by-beat cardiac output measurements during respiratory pauses under mechanical ventilation. In this way, it is possible to calculate MSP, the pressure gradient and the venous return resistances. The investigators aim is to explain the hemodynamic variations and the decrease in cardiac output observed during prone position. The investigators hypothesis is that venous return resistances are increased during prone position probably following an increased intra-abdominal pressure.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prone position | – | –Patient scheduled for surgery in the prone position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient scheduled for neurosurgery in the prone position
Key inclusion criteria (2 listed)
- Prone position neurosurgery
- High-risk neurosurgery
Key exclusion criteria (2 listed)
- Emergency surgery
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mean systemic pressure variation
Time frame: during surgery after the patient is put in prone position
change of mean systemic pressure from supine position to prone position during surgery
2 secondary outcomes
intrathoracic pressure variation
Time frame: during surgery during surgery after the patient is put in prone position
intravesical pressure variation
Time frame: during surgery during surgery after the patient is put in prone position
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
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.
Julien Pottecher, MD principal investigator
University Hospital of Strasbourg
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 Hemodynamic Variation During Surgery, run by University Hospital, Strasbourg, France at 1 site in France.
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 2 inclusion and 2 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 30 Sep 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 France. 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 Julien Pottecher, MD (+33(0)3 88 12 70 95, julien.pottecher@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean systemic pressure variation (time frame: during surgery after the patient is put in prone position). 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 30 Sep 2015; AzTrials last refreshed its copy on 29 Oct 2026.