Mini-fluid Challenge in Predicting Fluid Responsiveness During Prone Position Spine Surgery

The Effectiveness of Mini-fluid Challenge in Predicting Fluid Responsiveness During Prone Position Spine Surgery

Perioperative fluid management is crucial for patients' outcome. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Other: Mini-fluid challenge

Detailed Description

Perioperative fluid management is crucial for patients' outcome. Series of studies have indicated that adequate fluid management optimizes the cardiac out put, improves tissue perfusion, thus decrease the risk of postoperative morbidity. Muller et al developed a "Mini-fluid challenge method " to predict fluid responsiveness and the efficacy. To the best of our knowledge, the efficacy of the test was not discussed in the perioperative care in prone position surgery. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in prone position surgery.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University

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

Description

Inclusion Criteria: meet both of

1. Patients receiving scheduled prone position spine surgery
2. BMI 18.5~30 kg.m-2

Exclusion Criteria:

1. age younger then 20 yrs or elder than 80 yrs
2. pregnant women
3. patients in intensive care units
4. patients with the underlying disease including respiratory failure(FEV1/FVC < 70 % and FEV1 < 50%), heart failure(NYHA score =III、IV), kidney failure(eGFR< 60 ml.min-1.1.73m-2), liver failure
5. patients with ongoing infection
6. patients allergic to voluven

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mini-Fluid Challenge arm; Fluid challenge test will be presented after induction of anesthesia at a steady state. Fluid challenge test includes 2 components: 100 ml colloid infusion in 1 min followed by 400 ml colloid infusion in 14 mins. Hemodynamic parameter after 1 minute of the end of the 1st and 2nd colloid infusion bolus will be collected. Applied colloid: hydroxyethyl starch	Other: Mini-fluid challenge; Mini-fluid challenge test with 100mL colloid infusion in 1 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of cardiac index after fluid loading	interpretate the correlation of mini-fluid challenge and conventional fluid challenge	3hr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pulse pressure variation(PPV)	interpretate the correlation of PPV and conventional fluid challenge	3hr

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
stroke volume variation(SVV)	interpretate the correlation of SVV and conventional fluid challenge	3hr
plethysmographic variation index(PVI)	interpretate the correlation of PVI and conventional fluid challenge	3hr

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2017
• Primary Completion (ACTUAL): September 14, 2018
• Study Completion (ACTUAL): September 14, 2018

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (ACTUAL): March 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 9, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 201612021RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No