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Assessing the Diagnostic Accuracy of Corrected Flow Time (FTc) and Pleth Variability Index (PVI) as Predictors of Fluid Responsiveness in Patients in the Prone Position Using the Jackson Table

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02826889
Enrollment
58
Registered
2016-07-11
Start date
2016-05-24
Completion date
2017-07-27
Last updated
2017-10-02

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

Conditions

Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis, Scoliosis or Tumors, Spinal Fractures, Spondylolisthesis

Keywords

Fluid responsiveness, corrected flow time, pleth variability index, prone position

Brief summary

Appropriate fluid management is an important part of anesthesia in patients undergoing surgery, and several dynamic indices have been suggested to have high predictability for fluid responsiveness in patients receiving mechanical ventilation. Among various surgical positions, the prone position is known to cause unique physiologic and hemodynamic changes and affect the predictability and cut-off values of dynamic indices for fluid responsiveness. A previous study reported that pulse pressure variation (PPV) and corrected flow time were able to predict fluid responsiveness with relatively high accuracy in patients undergoing spine surgery in the prone position using a Wilson frame. However, the Jackson frame is known to have less effects on the cardiovascular system compared to the Wilson frame, and therefore may be physiologically more appropriate in patients undergoing surgery in the prone position. The pleth variability index (PVI) is a dynamic index that can be monitored non-invasively in patients under mechanical ventilation. The present study aims evaluate the validity of PPV and pleth variability index (PVI) as predictors of fluid responsiveness in the supine and prone positions in patients undergoing posterior lumbar spinal fusion using the Jackson table.

Interventions

DEVICEPhilips Intelivue MP70 monitor

Philips Intelivue MP70 monitor (Intellivue MP70, Philips medical Systems, Suresnes, France) -a radial arterial cannula is inserted and arterial pressure waveforms are monitored through Philips Intelivue MP70 monitor. In the monitor, PPVauto is displayed in real-time. It is based on automatic detection algorithms, kernel smoothing, and rank-order filters.

DEVICEPleth Variability Index (PVI)

PVI is the measure of the dynamic changes in the Perfusion Index (PI) that occur during one or more complete respiratory cycles. A rainbow Pulse CO-Oximetry sensor is attached to the patient's finger and the PVI is displayed in real-time on the Root monitor.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1\. Patients between the age of 19 and 75, scheduled for spine surgery under general anesthesia using the Jackson table

Exclusion criteria

1. Patient refusal 2. Patients that are not normal sinus rhythm on preoperative ECG 3. Patients with moderate\ severe cardiac valve disease 4. Patients with an ejection fraction under 50% 5. Significant lung disease 6. Obesity (BMI\>35kg/m2) 7. Patients with contraindications to esophageal doppler probe insertion 8. Illiterate patients or foreigners

Design outcomes

Primary

MeasureTime frameDescription
Pulse Pressure Variation (PPV)From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone positionFluid responsiveness predictability of FTc and PVI in patients undergoing posterior lumbar fusion in the prone position by using the Jackson frame by calculating area under the curve of the ROC curve.
Pleth Variability Index (PVI)From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026