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

Cardiac Surgical Procedures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457572
• Other study ID #: SMC 2014-07-005
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: September 11, 2015
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Surgical Procedures
• Sternotomy
• Thoracic Surgical Procedures

Intervention

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

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse pressure variation during Valsalva maneuver		during Valsalva maneuver	No
Secondary	Pulse pressure variation after sternotomy		5 min after sternotomy	No