- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01957605
Mean Systemic Pressure Measurement During Prone Position Surgery
September 29, 2015 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
40
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
-
-
-
Strasbourg, France, 67091
- Recruiting
- University Hospital of Strasbourg
-
Principal Investigator:
- Julien POTTECHER, MD
-
-
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
Patient scheduled for neurosurgery in the prone position
Description
Inclusion Criteria:
- Prone position neurosurgery
- High-risk neurosurgery
Exclusion Criteria:
- Emergency surgery
- Pregnancy
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
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
prone position
Patient scheduled for surgery in the prone position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
during surgery after the patient is put in prone position
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intrathoracic pressure variation
Time Frame: during surgery during surgery after the patient is put in prone position
|
Change of intrathoracic pressure from supine position to prone position during surgery
|
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
|
Change of intravesical pressure from supine position to prone position during surgery
|
during surgery during surgery after the patient is put in prone position
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Julien Pottecher, MD, University Hospital of Strasbourg
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
December 1, 2013
Primary Completion (Anticipated)
October 1, 2016
Study Completion (Anticipated)
October 1, 2016
Study Registration Dates
First Submitted
October 1, 2013
First Submitted That Met QC Criteria
October 7, 2013
First Posted (Estimate)
October 8, 2013
Study Record Updates
Last Update Posted (Estimate)
September 30, 2015
Last Update Submitted That Met QC Criteria
September 29, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 5673
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.
Clinical Trials on Hemodynamic Variation During Surgery
-
Philipps University Marburg Medical CenterKerckhoff Heart CenterCompletedHemodynamic Instability During Anesthesia | High Risk SurgeryGermany
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedHemodynamic Instability | Hypotension During SurgeryItaly
-
Seoul National University HospitalCompletedHemodynamic Responses During Tracheal IntubationKorea, Republic of
-
Marmara UniversityUnknownthe Hemodynamic Parameters | Intubation Times | Complications During and After IntubationTurkey
-
University of MilanRecruitingVariation of Keratinized Mucosa After Implant SurgeryItaly
-
University Hospital, LilleCompletedSurgery | Hemodynamic InstabilityFrance
-
University Hospital Schleswig-HolsteinCompleted
-
University of SalamancaCentro Hospitalar do PortoCompletedSurgery | Anesthesia | Hemodynamic InstabilityPortugal
-
Humanitas Clinical and Research CenterCompletedSurgery | Anesthesia | Hemodynamic InstabilityItaly
-
Hamad Medical CorporationRecruitingCardiac Surgery | Hemodynamic Monitoring | ICUQatar