Clinical Trial: Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Samsung Medical Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Conventional baseline PPV to predict fluid responsiveness [ Time Frame: when patients PPV in grey zone, before augmented ventilation ]

PPV value will be collected automatically by Intelivue philips patient monitor.


Original Secondary Outcome: Same as current

Information By: Samsung Medical Center

Dates:
Date Received: October 20, 2015
Date Started: September 2015
Date Completion:
Last Updated: March 2, 2016
Last Verified: March 2016