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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Neoplasms; Gynecologic Neoplasms
• Intervention / Treatment: Other: Augmented ventilation; Other: Fluid loading

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective open laparotomy surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Augmented ventilation with 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.

Other: Augmented 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.; Other: Fluid loading; We record the stroke volume index (SVI) values before and after volume expansion with 6ml/kg of balanced crystalloid; Other Names: Balanced crystalloid infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Augmented PPV (Pulse Pressure Variation) to predict fluid responsiveness	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.	within 2 min from augmented ventilation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• Min 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: January 9, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Estimate): March 4, 2016
• Last Update Submitted That Met QC Criteria: March 2, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Female; Abdominal Neoplasms
• Other Study ID Numbers: SMC 2015-06-015