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Pulse Pressure Variation in Spontaneously Breathing Patients

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01402934
First received: May 29, 2011
Last updated: April 20, 2016
Last verified: July 2011
  Purpose
The investigators hypothesized that pulse pressure variation (PPV) could predict fluid responsiveness in spontaneously breathing patients undergoing anesthesia induction.

Condition Intervention
Pulse Pressure Variation
Spontaneously Breathing
Procedure: Hydroxyethyl starch solution (Voluven) infusion

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Ability of Pulse Pressure Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients Undergoing Thoracic Surgery

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • pulse pressure variation [ Time Frame: three respiratory cycles, an expected average of 30 seconds ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hemodynamic parameters [ Time Frame: before and after fluid loading, 1 mimute ] [ Designated as safety issue: No ]
    systolic blood pressure (SBP), dyastolic BP, mean BP, heart rate, cardiac index, stroke volume varation


Enrollment: 70
Study Start Date: May 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fluid infusion Procedure: Hydroxyethyl starch solution (Voluven) infusion
fluid loading will be performed by hydroxyethyl starch solution (Voluven), at 6 mL/kg

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01402934

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Responsible Party: Jae-Hyon Bahk, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01402934     History of Changes
Other Study ID Numbers: JHBahk_PPV 
Study First Received: May 29, 2011
Last Updated: April 20, 2016
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes

ClinicalTrials.gov processed this record on December 02, 2016