ClinicalTrials.gov
ClinicalTrials.gov Menu

Mean Systemic Pressure Measurement During Prone Position Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01957605
Recruitment Status : Unknown
Verified September 2015 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : October 8, 2013
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief 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. 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.

Condition or disease
Hemodynamic Variation During Surgery

Study Type : Observational
Estimated Enrollment : 40 participants
Time Perspective: Cross-Sectional
Official Title: Study of Hemodynamic Variations During Prone Position Surgery: Measurement of Mean Systemic Pressure and Venous Return Resistance
Study Start Date : December 2013
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Group/Cohort
prone position
Patient scheduled for surgery in the prone position



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient scheduled for neurosurgery in the prone position
Criteria

Inclusion Criteria:

  • Prone position neurosurgery
  • High-risk neurosurgery

Exclusion Criteria:

  • Emergency surgery
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957605


Contacts
Contact: Julien Pottecher, MD +33(0)3 88 12 70 95 julien.pottecher@chru-strasbourg.fr

Locations
France
University Hospital of Strasbourg Recruiting
Strasbourg, France, 67091
Principal Investigator: Julien Pottecher, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Julien Pottecher, MD University Hospital of Strasbourg

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01957605     History of Changes
Other Study ID Numbers: 5673
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015

Keywords provided by University Hospital, Strasbourg, France:
prone position
hemodynamic variation
mean systemic pressure