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CompletedNCT02826889Updated Oct 2, 2017

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

An interventional study of Philips Intelivue MP70 monitor and Pleth Variability Index (PVI) in Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis, Spondylolisthesis and Spinal Fractures, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-02.

Sponsored by Yonsei University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Not applicable
Ages
19 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Fluid responsiveness
  • corrected flow time
  • pleth variability index
  • prone position
03

In context

Scoliosis

594 studies on the registry are indexed under Scoliosis; 138 are open to participants now.

This study's enrollment of 58 is above the median of 44 across 344 interventional studies indexed under Scoliosis.

Browse Scoliosis studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Fluid loading group

    Device: Philips Intelivue MP70 monitor · Device: Pleth Variability Index (PVI)

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.

06

What researchers measure

Primary outcomes

  1. Pulse Pressure Variation (PPV)

    Fluid 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.

    Time frame: From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position

  2. Pleth Variability Index (PVI)

    Time frame: From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
    Seoul, 03722, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02826889
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Jul 11, 2016
Start date
May 24, 2016
Primary completion
Jul 27, 2017
Completion
Jul 27, 2017
Last update
Oct 2, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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