- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02457572
Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition
September 11, 2015 updated by: Jong Hwan Lee, Samsung Medical Center
Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition in the Patients Undergoing Off-pump Coronary Arterial Bypass Grafting
Pulse pressure variation (PPV) is a well-known dynamic preload indicator to predict fluid responsiveness.
However, its usefulness in open-chest conditions has been equivocal.
The investigators evaluated whether PPV measured during Valsalva maneuver can predict fluid responsiveness after sternotomy.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult patients undergoing elective off-pump coroanry arterial bypass grafting
Description
Inclusion Criteria:
- Adult patients undergoing elective off-pump coronary arterial bypass grafting
Exclusion Criteria:
- Preoperative LV EF <= 35%
- Moderate or severe valvular heart disease
- Cardiac arrhythmia
- Intracardiac shunt
- Severe renal or liver disease
- Moderate to severe pulmonary hypertension (mean PAP > 35 mmHg)
- Patients with bullous lung disease or combined pneumothorax
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Valsalva maneuver
This is an observational study and as a diagnostic intervention, subjects in the study would receive valsalva maneuver.
Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration.
The investigators perform this procedure to every patients and do not assign this intervention to the subjects of the study.
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Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration.
Other Names:
We record the cardiac index values before and after volume expansion with 6ml/kg of balanced crystalloid
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pulse pressure variation during Valsalva maneuver
Time Frame: during Valsalva maneuver
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during Valsalva maneuver
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Pulse pressure variation after sternotomy
Time Frame: 5 min after sternotomy
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5 min after sternotomy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (ACTUAL)
May 1, 2015
Study Completion (ACTUAL)
May 1, 2015
Study Registration Dates
First Submitted
April 22, 2015
First Submitted That Met QC Criteria
May 26, 2015
First Posted (ESTIMATE)
May 29, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
September 14, 2015
Last Update Submitted That Met QC Criteria
September 11, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- SMC 2014-07-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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