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

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

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
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.
Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration.
Other Names:
  • Lung recruitment maneuver
We record the cardiac index values before and after volume expansion with 6ml/kg of balanced crystalloid
Other Names:
  • Balanced crystalloid infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulse pressure variation during Valsalva maneuver
Time Frame: during Valsalva maneuver
during Valsalva maneuver

Secondary Outcome Measures

Outcome Measure
Time Frame
Pulse pressure variation after sternotomy
Time Frame: 5 min after sternotomy
5 min after sternotomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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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