NCT03731377

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
1.9 years until next milestone

Study Start

First participant enrolled

October 7, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

October 1, 2018

Last Update Submit

October 5, 2020

Conditions

Mini-fluid Challenge in Video-Assisted Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • Change of blood pressure after fluid loading

    Interpretate the correlation of mini-fluid challenge and conventional fluid challenge

    3 hours

Secondary Outcomes (1)

  • Change of cardiac index after fluid loading

    3 hours

Other Outcomes (5)

  • stroke volume variation(SVV)

    3 hours

  • stroke volume (SV)

    3 hours

  • stroke volume index(SVI)

    3 hours

  • +2 more other outcomes

Study Arms (2)

Intubated group

EXPERIMENTAL

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

Non-intubated group

EXPERIMENTAL

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

Interventions

Crystalloid SolutionsDRUG

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.

Intubated groupNon-intubated group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (4)

  • 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.

    PMID: 22617510BACKGROUND

  • 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.

    PMID: 18212731BACKGROUND

  • 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.

    PMID: 21792055BACKGROUND

  • 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.

    PMID: 20477782BACKGROUND

MeSH Terms

Interventions

Crystalloid Solutions

Intervention Hierarchy (Ancestors)

Isotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Tzu Jung Wei

CONTACT

+886972653416sa46222@gmail.com

National Taiwan University Hospital

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2018

First Posted

November 6, 2018

Study Start

October 7, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

TW(1)