Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Neoplasms | — | UNRESOLVED | — |
| Gynecologic Neoplasms | Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Augmented ventilation | Other | — | UNRESOLVED |
| Fluid loading | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Augmented ventilation with fluid loading
- description
- 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.
- interventionNames
- Other: Augmented ventilation
- Other: Fluid loading
Primary outcomes (1)
- measure
- Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness
- timeFrame
- within 2 min from augmented ventilation
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMin JJ, Gil NS, Lee JH, Ryu DK, Kim CS, Lee SM. Predictor of fluid responsiveness in the 'grey zone': augmented pulse pressure variation through a temporary increase in tidal volume. Br J Anaesth. 2017 Jul 1;119(1):50-56. doi: 10.1093/bja/aex074. PMID 28974059