Skip to main content
Clinical Trials/NCT02653469
NCT02653469
Completed
Not Applicable

Pulse Pressure Variation With Augmented Ventilation to Predict Fluid Responsiveness in the Patients Undergoing Open Laparotomy Surgery

Samsung Medical Center1 site in 1 country38 target enrollmentSeptember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gynecologic Neoplasms
Sponsor
Samsung Medical Center
Enrollment
38
Locations
1
Primary Endpoint
Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Pulse pressure variation (PPV) is a well-known and widely used dynamic preload indicator based on heart-lung interaction to predict fluid responsiveness. Generally, patients are considered to be fluid-responsive when the PPV value larger than 11-13%. However, several previous researches demonstrated that there is a zone of uncertainty (grey zone) in PPV. To predict fluid-responsiveness accurately in the patients with PPV within grey zone (9-13%), the investigators would evaluate the augmented PPV using augmented ventilation.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
February 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jong Hwan Lee

Assistant professor

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

  • Adult patients undergoing elective open laparotomy surgery.

Exclusion Criteria

  • Irregular heart beats,
  • cardiac arrhythmia,
  • moderate or severe valvular heart disease,
  • preoperative left ventriular ejection fraction less than 40%,
  • moderate t severe obstructive pulmonary disease,
  • preoperative need of inotropics infusion,
  • preoperative serum Cr \> 1.3ml/dl,
  • moderate to severe renal or liver disease,
  • acute lung injury or acute lung problem,
  • coexisting open chest condition,

Outcomes

Primary Outcomes

Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness

Time Frame: within 2 min from augmented ventilation

Augmented ventilation (12ml/kg) will be performed when the participant's PPV is within grey zone (9-13%). PPV value will be collected automatically by Intelivue philips patient monitor. Percentage changes in stroke volume index by EV1000 according to fluid loading were used as principal indicators of fluid responsiveness. Patients were classified as responders or non-responders when increases in SVI were ≥ 10% or \<10% after volume loading (crystalloid iv 6ml/kg). To test the abilities of augmented PPV to predict fluid responsiveness, areas under the receiver operating characteristics (ROC) curves of the responders \[area under the curve (AUC) = 0.5: no better than chance, no prediction possible; AUC = 1.0: best possible prediction\] will be calculated.

Secondary Outcomes

  • Conventional baseline PPV to predict fluid responsiveness(when patients PPV in grey zone, before augmented ventilation)

Study Sites (1)

Loading locations...

Similar Trials