Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy

Completed

• Conditions: Gynecologic Neoplasms; Abdominal Neoplasms
• Interventions: Other: Augmented ventilation; Other: Fluid loading

• Registration Number: NCT02653469
• Lead Sponsor: Samsung Medical Center

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2016-01-09
• Study First Posted: 2016-01-12
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-02
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Adult patients undergoing elective open laparotomy surgery.

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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,
• severe bradycardia,
• patients with spontaneous breathing

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Augmented ventilation with fluid loading	Augmented ventilation	This is an observational study and as a diagnostic intervention, subjects in the study would receive mechanical ventilation with augmented tidal volume of 12ml/kg for 2min. Augmented ventilation is performed when the patient's PPV is within grey zone (9-13%). The investigators perform this procedure to every patients and do not assigh this intervention to the subjects of the study. Then, 6ml/kg of ballanced crystalloid loading will be infused to every patient.
Augmented ventilation with fluid loading	Fluid loading	This is an observational study and as a diagnostic intervention, subjects in the study would receive mechanical ventilation with augmented tidal volume of 12ml/kg for 2min. Augmented ventilation is performed when the patient's PPV is within grey zone (9-13%). The investigators perform this procedure to every patients and do not assigh this intervention to the subjects of the study. Then, 6ml/kg of ballanced crystalloid loading will be infused to every patient.

Primary Outcome Measures

Name	Time	Method
Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness	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 Outcome Measures

Name	Time	Method
Conventional baseline PPV to predict fluid responsiveness	when patients PPV in grey zone, before augmented ventilation	PPV value will be collected automatically by Intelivue philips patient monitor.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of