Pulse Pressure Variation in Spontaneously Breathing Patients

Pulse Pressure Variation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402934
• Other study ID #: JHBahk_PPV
• Status: Completed
• Phase: N/A
• First received: May 29, 2011
• Last updated: April 20, 2016
• Start date: May 2011
• Est. completion date: October 2011

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulse Pressure Variation
• Respiratory Aspiration
• Spontaneously Breathing

Intervention

Procedure:
• Hydroxyethyl starch solution (Voluven) infusion
fluid loading will be performed by hydroxyethyl starch solution (Voluven), at 6 mL/kg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulse pressure variation		three respiratory cycles, an expected average of 30 seconds	No
Secondary	hemodynamic parameters	systolic blood pressure (SBP), dyastolic BP, mean BP, heart rate, cardiac index, stroke volume varation	before and after fluid loading, 1 mimute	No