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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

Tracking Information
First Submitted Date April 22, 2015
First Posted Date May 29, 2015
Last Update Posted Date September 14, 2015
Study Start Date October 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2015)
Pulse pressure variation during Valsalva maneuver [ Time Frame: during Valsalva maneuver ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 26, 2015)
Pulse pressure variation after sternotomy [ Time Frame: 5 min after sternotomy ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pulse Pressure Variation Measured During Valsalva Maneuver to Predict Fluid Responsiveness Under Open-chest Condition
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients undergoing elective off-pump coroanry arterial bypass grafting
Condition
  • Cardiac Surgical Procedures
  • Thoracic Surgical Procedures
  • Sternotomy
Intervention
  • 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
Study Groups/Cohorts 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.
Interventions:
  • Procedure: Valsalva maneuver
  • Other: Fluid loading
Publications * Min JJ, Kim TK, Lee JH, Park J, Cho HS, Kim WS, Lee YT. Evaluation of augmented pulse pressure variation using the Valsalva manoeuvre as a predictor of fluid responsiveness under open-chest conditions: A prospective observational study. Eur J Anaesthesiol. 2017 May;34(5):254-261. doi: 10.1097/EJA.0000000000000613.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 11, 2015)
55
Original Estimated Enrollment
 (submitted: May 26, 2015)
60
Actual Study Completion Date May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02457572
Other Study ID Numbers SMC 2014-07-005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jong Hwan Lee, Samsung Medical Center
Study Sponsor Samsung Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Samsung Medical Center
Verification Date September 2015