The Effectiveness of Mini-fluid Challenge in Predicting Fluid Responsiveness During Video Assisted Thoracic Surgery

NCT ID: NCT03731377

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-07

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mini-fluid Challenge in Video-Assisted Thoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Crystalloid Solutions

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

Crystalloid Solutions

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tzu Jung Wei

Role: CONTACT

+886972653416

National Taiwan University Hospital

Role: CONTACT

Facility Contacts

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Wu Chun-Yu, Ph.D.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22617510 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18212731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21792055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20477782 (View on PubMed)

Other Identifiers

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201807009RINC

Identifier Type: -

Identifier Source: org_study_id

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