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

Not Applicable

Completed

• Conditions: Spondylolisthesis; Spinal Fractures; Scoliosis or Tumors; Elective Posterior Lumbar Spinal Fusion for Spinal Stenosis
• Interventions: Device: Philips Intelivue MP70 monitor; Device: Pleth Variability Index (PVI)

• Registration Number: NCT02826889
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-24
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-11
• Primary Completion: 2017-07-27
• Study Completion: 2017-07-27
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluid loading group	Philips Intelivue MP70 monitor	-
Fluid loading group	Pleth Variability Index (PVI)	-

Primary Outcome Measures

Name	Time	Method
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
Pulse Pressure Variation (PPV)	From 15 minutes after induction of anesthesia in the supine position to 5 minutes after fluid loading in the prone position	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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of