Pulse Pressure Variation in Spontaneously Breathing Patients

NCT ID: NCT01402934

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-10-31

Brief Summary

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

Detailed Description

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.

Conditions

Pulse Pressure Variation; Spontaneously Breathing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

fluid infusion

Group Type: EXPERIMENTAL

Hydroxyethyl starch solution (Voluven) infusion

Intervention Type: PROCEDURE

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

Interventions

Hydroxyethyl starch solution (Voluven) infusion

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

JHBahk_PPV

Identifier Type: -

Identifier Source: org_study_id