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

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.

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