Pulse Pressure Variations as Index of Preload Dependency During Thoracic Surgery
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|ClinicalTrials.gov Identifier: NCT01329146|
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : May 13, 2016
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 or disease|
- pulse pressure variation
- preload dependency
- one-lung ventilation
- thoracic surgery
|Study Type :||Observational|
|Actual Enrollment :||17 participants|
|Official Title:||Pulse Pressure Variations as Index of Preload Dependency During Thoracic Surgery|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
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
|Thoracic surgery department, University Hospital of Lille|
|Lille, France, 59000|
|Principal Investigator:||Emmanuel ROBIN, MD PhD||Reanimation Department, University Hospital of Lille|