The Effectiveness of Mini-fluid Challenge in Predicting Fluid Responsiveness During Video Assisted Thoracic 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 video assisted thoracic surgery.

Study Overview

• Status: Unknown
• Conditions: Mini-fluid Challenge in Video-Assisted Thoracic Surgery
• Intervention / Treatment: Drug: Crystalloid Solutions

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. Fluid status and proper perfusion condition in patients undergo thoracic surgery are especially crucial for the vulnerability of lung toward fluid overload. To the best of our knowledge, the efficacy of the test was not discussed in the perioperative care in video assisted thoracic surgery. The investigators design the study to investigate the effectiveness of mini-fluid challenge test in video assisted thoracic surgery.

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

Contacts and Locations

• Study Contact: Name: Tzu Jung Wei; Phone Number: +886972653416; Email: sa46222@gmail.com
• Study Contact Backup: Name: National Taiwan University Hospital

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Wu Chun-Yu, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients receiving scheduled video assisted thoracic surgery
• BMI 18.5~30 kg.m-2

Exclusion Criteria:

• age younger then 20 yrs or elder than 80 yrs
• pregnant women
• patients in intensive care units
• 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
• patients with ongoing infection
• patient allergic to voluven

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intubated group; Patient in this group will receive general anesthesia with endotracheal tube intubation to perform one lung ventilation. Patient will be paralyzed and controlled ventilation will be implied.	Drug: Crystalloid Solutions; Mini-fluid challenge with crystalloid 250 ml will be given to patients first. After observation of hemodynamic parameters, further fluid challenge will be given for response observation.
Experimental: Non-intubated group; Patient in this group will receive general anesthesia with laryngeal mask insertion. Patients in this group will not be paralyzed and keep spontaneous breathing to maintain one lung ventilation.	Drug: Crystalloid Solutions; Mini-fluid challenge with crystalloid 250 ml will be given to patients first. After observation of hemodynamic parameters, further fluid challenge will be given for response observation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of blood pressure after fluid loading	Interpretate the correlation of mini-fluid challenge and conventional fluid challenge	3 hours

Secondary 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	3 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
stroke volume variation(SVV)	Interpretate the correlation of mini-fluid challenge and conventional fluid challenge	3 hours
stroke volume (SV)	Interpretate the correlation of mini-fluid challenge and conventional fluid challenge	3 hours
stroke volume index(SVI)	Interpretate the correlation of mini-fluid challenge and conventional fluid challenge	3 hours
plethysmographic variation index(PVI)	Interpretate the correlation of mini-fluid challenge and conventional fluid challenge	3 hours
pulse pressure variation(PPV)	Interpretate the correlation of mini-fluid challenge and conventional fluid challenge	3 hours

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Publications and helpful links

General Publications

• Cavallaro F, Sandroni C, Antonelli M. Functional hemodynamic monitoring and dynamic indices of fluid responsiveness. Minerva Anestesiol. 2008 Apr;74(4):123-35. Epub 2008 Jan 24.
• Evans RG, Naidu B. Does a conservative fluid management strategy in the perioperative management of lung resection patients reduce the risk of acute lung injury? Interact Cardiovasc Thorac Surg. 2012 Sep;15(3):498-504. doi: 10.1093/icvts/ivs175. Epub 2012 May 22.
• Vincent JL. "Let's give some fluid and see what happens" versus the "mini-fluid challenge". Anesthesiology. 2011 Sep;115(3):455-6. doi: 10.1097/ALN.0b013e318229a521. No abstract available.
• Wyffels PA, Sergeant P, Wouters PF. The value of pulse pressure and stroke volume variation as predictors of fluid responsiveness during open chest surgery. Anaesthesia. 2010 Jul;65(7):704-9. doi: 10.1111/j.1365-2044.2010.06371.x. Epub 2010 May 6.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 7, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: November 4, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: 201807009RINC

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