Pulse Pressure VariationNCT01402934
Pulse Pressure Variation in Spontaneously Breathing Patients
A study testing Hydroxyethyl starch solution (Voluven) infusion in people with Pulse Pressure Variation and Spontaneously Breathing, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators hypothesized that pulse pressure variation (PPV) could predict fluid responsiveness in spontaneously breathing patients undergoing anesthesia induction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulse Pressure Variation, Spontaneously Breathing
- What is being tested?
- Hydroxyethyl starch solution (Voluven) infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing thoracic surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
Official title: The Ability of Pulse Pressure Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients Undergoing Thoracic Surgery
The investigators hypothesized that pulse pressure variation (PPV) could predict fluid responsiveness in spontaneously breathing patients undergoing anesthesia induction.
Read the 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
- Being tested
- Hydroxyethyl starch solution (Voluven) infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethyl starch solution (Voluven) infusionProcedure or surgery
fluid loading will be performed by hydroxyethyl starch solution (Voluven), at 6 mL/kg
| Study group | Role | What they receive |
|---|---|---|
| fluid infusion | Experimental | Not described Receives: Procedure: Hydroxyethyl starch solution (Voluven) infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulse pressure variation
Measured: three respiratory cycles, an expected average of 30 seconds
Secondary outcomes (1)
hemodynamic parameters
systolic blood pressure (SBP), dyastolic BP, mean BP, heart rate, cardiac index, stroke volume varation
Measured: before and after fluid loading, 1 mimute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse Pressure VariationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402934
- Sponsor's protocol ID
- JHBahk_PPV
- Status last verified
- Jul 2011
- First submitted
- 29 May 2011
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Pulse Pressure Variation to Predict Fluid Responsiveness in Spontaneously Breathing Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT01402934
- Acronym / sponsor ID
- JHBahk_PPV
- Conditions
- Pulse Pressure Variation, Spontaneously Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fluid infusion | Experimental | Procedure: Hydroxyethyl starch solution (Voluven) infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing thoracic surgery
Key exclusion criteria (7 listed)
- preoperative arrhythmia
- left ventricular ejection fraction <40%
- intra-cardiac valve disease
- intra-cardiac shunt
- pulmonary artery hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyethyl starch solution (Voluven) infusionfluid loading will be performed by hydroxyethyl starch solution (Voluven), at 6 mL/kg | Procedure or surgery | fluid infusion |
Primary outcome
pulse pressure variation
Time frame: three respiratory cycles, an expected average of 30 seconds
1 secondary outcome
hemodynamic parameters
Time frame: before and after fluid loading, 1 mimute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
Related trials for Pulse Pressure Variation
RecruitingObservational study
Association Between Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in Cardiac Surgery
Coronary Artery Disease
RecruitingObservational study
Dynamic Arterial Elastance for Prediction of Vasopressor Requirement After Anesthesia Induction in Elective On-Pump CABG
Coronary Artery Disease
Recruiting
Hemodynamic Effects of Bilateral and Unilateral Spinal Anesthesia Using the Continuous Pressure Recording Analytical Method.
Spinal Anesthesia, Hemodynamic Changes
RecruitingObservational study
Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness
Hemodynamic Instability
Not yet recruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyethyl starch solution (Voluven) infusion in people with Pulse Pressure Variation and Spontaneously Breathing, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulse pressure variation (time frame: three respiratory cycles, an expected average of 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.