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Augmented Pulse Pressure Variation to Predict Fluid Responsiveness in Open Laparotomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02653469
Enrollment
38
Registered
2016-01-12
Start date
2015-09-30
Completion date
2016-02-29
Last updated
2016-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Neoplasms, Abdominal Neoplasms

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.

Interventions

OTHERAugmented ventilation

When the patient's PPV is within grey zone, patient's tidal volume is maintained with augmented tidal volume of 12 ml/kg (from normal ventilation of 8ml/kg) for 2min duration.

We record the stroke volume index (SVI) values before and after volume expansion with 6ml/kg of balanced crystalloid

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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, * severe bradycardia, * patients with spontaneous breathing

Design outcomes

Primary

MeasureTime frameDescription
Augmented PPV (Pulse Pressure Variation) to predict fluid responsivenesswithin 2 min from augmented ventilationAugmented 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

MeasureTime frameDescription
Conventional baseline PPV to predict fluid responsivenesswhen patients PPV in grey zone, before augmented ventilationPPV value will be collected automatically by Intelivue philips patient monitor.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026