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Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition

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ClinicalTrials.gov Identifier: NCT02457572
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : September 14, 2015
Sponsor:
Information provided by (Responsible Party):
Jong Hwan Lee, Samsung Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiac Surgical Procedures Thoracic Surgical Procedures Sternotomy Procedure: Valsalva maneuver Other: Fluid loading

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : October 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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.
Procedure: Valsalva maneuver
Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration.
Other Name: Lung recruitment maneuver

Other: Fluid loading
We record the cardiac index values before and after volume expansion with 6ml/kg of balanced crystalloid
Other Name: Balanced crystalloid infusion




Primary Outcome Measures :
  1. Pulse pressure variation during Valsalva maneuver [ Time Frame: during Valsalva maneuver ]

Secondary Outcome Measures :
  1. Pulse pressure variation after sternotomy [ Time Frame: 5 min after sternotomy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing elective off-pump coroanry arterial bypass grafting
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457572


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jong Hwan Lee, Assistant professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02457572    
Other Study ID Numbers: SMC 2014-07-005
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015