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Pulse Pressure Variation in Spontaneously Breathing Patients

Primary Purpose

Pulse Pressure Variation, Spontaneously Breathing

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Hydroxyethyl starch solution (Voluven) infusion
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulse Pressure Variation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fluid infusion

Arm Description

Outcomes

Primary Outcome Measures

pulse pressure variation

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2011
Last Updated
April 20, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01402934
Brief Title
Pulse Pressure Variation in Spontaneously Breathing Patients
Official Title
The Ability of Pulse Pressure Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients Undergoing Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulse Pressure Variation, Spontaneously Breathing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fluid infusion
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Hydroxyethyl starch solution (Voluven) infusion
Intervention Description
fluid loading will be performed by hydroxyethyl starch solution (Voluven), at 6 mL/kg
Primary Outcome Measure Information:
Title
pulse pressure variation
Time Frame
three respiratory cycles, an expected average of 30 seconds
Secondary Outcome Measure Information:
Title
hemodynamic parameters
Description
systolic blood pressure (SBP), dyastolic BP, mean BP, heart rate, cardiac index, stroke volume varation
Time Frame
before and after fluid loading, 1 mimute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Pulse Pressure Variation in Spontaneously Breathing Patients

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