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Pulse Pressure Variations as Index of Preload Dependency During Thoracic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01329146
First Posted: April 5, 2011
Last Update Posted: May 13, 2016
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.
Information provided by (Responsible Party):
University Hospital, Lille
  Purpose

Background: calculation of the pulse pressure variation (PPV) has repeatedly been shown to be a reliable predictor of fluid responsiveness in mechanically ventilated patients. But PPV measurement has not been yet validated in thoracic surgery during one-lung ventilation. The modifications of intrathoracic pressure induced by one-lung ventilation may altered the capabilities of PPV to predict fluid responsiveness.This study was designed to assess the ability of PPV predict fluid responsiveness during one-lung ventilation in thoracic surgery.

Methods: a prospective observational study. Thirty five patients undergoing a pulmonary resection (lobectomy or pneumonectomy) will be included to achieve around one hundred fluid challenges with a 250 milliliters colloid solution in response to hemodynamic instability.Hemodynamic instability is defined as a decrease by 20 % of artery pressure from baseline and/or an increase by 20% heart rate from baseline. Fluid responsiveness is defined as an increase in stroke volume index (SVI)>10% (measured with oesophageal doppler). PPV will be calculated from recorded artery pressure curve (PPVref) before and after each fluid challenge. An automated measurement of PPV proposed by the monitor Intelview (Philips) will be recorded simultaneously before and after each fluid challenge.

Statistical analysis: receiver operating characteristic curve will be used to assess the PPV capability to predict fluid responsiveness. Correlation analysis will be achieved using a Pearson test or Spearman's rho test when necessary. Continuous data will compared using a Student t test or a Mann-Whitney test when necessary.


Condition
Fluid Response

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulse Pressure Variations as Index of Preload Dependency During Thoracic Surgery

Further study details as provided by University Hospital, Lille:

Enrollment: 17
Study Start Date: October 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:
  • pulse pressure variation
  • preload dependency
  • one-lung ventilation
  • thoracic surgery
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing a thoracic surgery (lobectomy or pneumonectomy)and requiring hemodynamic monitoring (artery catheter, oesophageal doppler)in the thoracic surgery unit of the university hospital of Lille.
Criteria

Inclusion Criteria:

  • All patients undergoing a thoracic surgery (lobectomy, bilobectomy or pneumonectomy).
  • All patients requiring a hemodynamic monitoring (artery catheter, oesophageal doppler).

Exclusion Criteria:

  • Arrythmia.
  • Pregnant patient.
  • Patients less than 18 years old.
  • oesophageal or gastric pathologies precluding the use of oesophageal doppler.
  • pathologies precluding the use of artery catheter.
  Contacts and Locations
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): NCT01329146


Locations
France
Thoracic surgery department, University Hospital of Lille
Lille, France, 59000
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Emmanuel ROBIN, MD PhD Reanimation Department, University Hospital of Lille
  More Information

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01329146     History of Changes
Other Study ID Numbers: 2008-A00302-53
PROM 2008/0812 ( Other Identifier: Sponsor )
First Submitted: April 4, 2011
First Posted: April 5, 2011
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Lille:
pulse pressure variation
preload dependency
one-lung ventilation
thoracic surgery