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Completed

NCT Number: NCT01402934

Pulse Pressure Variation in Spontaneously Breathing Patients

The investigators hypothesized that pulse pressure variation (PPV) could predict fluid responsiveness in spontaneously breathing patients undergoing anesthesia induction.

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Key information

Conditions

Pulse Pressure Variation Spontaneously Breathing

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

Pulse pressure variation (PPV) is known to be a dynamic indicator to predict fluid responsiveness in mechanically ventilating patients. PPV is generated by cardiopulmonary interaction with respiratory cycles. In spontaneous breathing, the cardiopulmonary interaction may lead to PPV by inverted manner. In this study, the investigators will evaluate the ability of PPV to predict fluid responsiveness in spontaneously breathing patients. Before induction of anesthesia, radial artery cannulation is performed, and FloTrac/Vigileo (Edwards Lifesciences Corp., Irvine, USA) system is connected. And then, the investigators will measure baseline data including invasive blood pressure, pulse pressure, cardiac index, stroke volume variation in two different conditions: during tidal spontaneous breathing and during forced spontaneous breathing. All hemodynamic measurement will be repeated after infusion of fluid using 6mL/kg of hydroxyethyl starch solution (Voluven), and will be averaged over 3 minutes. Patients whose cardiac index increased by >15% to fluid infusion is defined as responders. The investigators will compare the hemodynamic parameters between responders and non-responders. To evaluate the ability to predict volume responsiveness, receiver operating characteristics curves of the PPV will be calculated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing thoracic surgery

Exclusion criteria

  • preoperative arrhythmia
  • left ventricular ejection fraction <40%
  • intra-cardiac valve disease
  • intra-cardiac shunt
  • pulmonary artery hypertension
  • severe peripheral vascular obstructive disease
  • decreased pulmonary function

Treatment and study plan

Hydroxyethyl starch solution (Voluven) infusion

Procedure

fluid loading will be performed by hydroxyethyl starch solution (Voluven), at 6 mL/kg

Primary outcomes

  1. pulse pressure variation

    Time frame: three respiratory cycles, an expected average of 30 seconds

Secondary outcomes

  1. hemodynamic parameters

    Time frame: before and after fluid loading, 1 mimute

    systolic blood pressure (SBP), dyastolic BP, mean BP, heart rate, cardiac index, stroke volume varation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Ability of Pulse Pressure Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients Undergoing Thoracic Surgery

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 26, 2011
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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