Pulse Pressure Variations as Index of Preload Dependency During Thoracic Surgery

Fluid Response Clinical Trial

Official title:

Pulse Pressure Variations as Index of Preload Dependency During Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329146
• Other study ID #: 2008-A00302-53
• Secondary ID: PROM 2008/0812
• Status: Completed
• Phase: N/A
• First received: April 4, 2011
• Last updated: May 12, 2016
• Start date: October 2008
• Est. completion date: June 2009

Study information

• Verified date: May 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Description:

• pulse pressure variation

• preload dependency

• one-lung ventilation

• thoracic surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fluid Response

Locations

Country	Name	City	State
France	Thoracic surgery department, University Hospital of Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France,