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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

Primary Purpose

Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis, Spondylolisthesis, Spinal Fractures

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Philips Intelivue MP70 monitor
Pleth Variability Index (PVI)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis focused on measuring Fluid responsiveness, corrected flow time, pleth variability index, prone position

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluid loading group

Arm Description

Outcomes

Primary Outcome Measures

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.
Pleth Variability Index (PVI)

Secondary Outcome Measures

Full Information

First Posted
July 6, 2016
Last Updated
September 28, 2017
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02826889
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 24, 2016 (Actual)
Primary Completion Date
July 27, 2017 (Actual)
Study Completion Date
July 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluid loading group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Philips Intelivue MP70 monitor
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Pleth Variability Index (PVI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulse Pressure Variation (PPV)
Description
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Patients between the age of 19 and 75, scheduled for spine surgery under general anesthesia using the Jackson table Exclusion Criteria: Patient refusal Patients that are not normal sinus rhythm on preoperative ECG Patients with moderate~severe cardiac valve disease Patients with an ejection fraction under 50% Significant lung disease Obesity (BMI>35kg/m2) Patients with contraindications to esophageal doppler probe insertion Illiterate patients or foreigners
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

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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

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