Pulse Pressure Variation in Spontaneously Breathing Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01402934
First received: May 29, 2011
Last updated: July 28, 2011
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


Estimated Enrollment: 70
Study Start Date: May 2011
Estimated Study Completion Date: October 2011
Estimated 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
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

Contacts
Contact: Jae-Hyon Bahk, PhD, MD 82-2-2072-2818 bahkjh@plaza.snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jae-Hyon Bahk, PhD, MD    82-2-2072-2818    bahkjh@snu.ac.kr   
Contact: Deok Man Hong, PhD, MD    82-2-2072-2469    mellyn7@gmail.com   
Principal Investigator: Jae-Hyon Bahk, PhD, MD         
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

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: July 28, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Aspiration
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Hydroxyethyl Starch Derivatives
Blood Substitutes
Hematologic Agents
Pharmacologic Actions
Plasma Substitutes
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014