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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03731377
Other study ID # 201807009RINC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 7, 2020
Est. completion date November 2021

Study information

Verified date October 2020
Source National Taiwan University Hospital
Contact Tzu Jung Wei
Phone +886972653416
Email sa46222@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 2021
Est. primary completion date November 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other stroke volume variation(SVV) Interpretate the correlation of mini-fluid challenge and conventional fluid challenge 3 hours
Other stroke volume (SV) Interpretate the correlation of mini-fluid challenge and conventional fluid challenge 3 hours
Other stroke volume index(SVI) Interpretate the correlation of mini-fluid challenge and conventional fluid challenge 3 hours
Other plethysmographic variation index(PVI) Interpretate the correlation of mini-fluid challenge and conventional fluid challenge 3 hours
Other pulse pressure variation(PPV) Interpretate the correlation of mini-fluid challenge and conventional fluid challenge 3 hours
Primary Change of blood pressure after fluid loading Interpretate the correlation of mini-fluid challenge and conventional fluid challenge 3 hours
Secondary Change of cardiac index after fluid loading Interpretate the correlation of mini-fluid challenge and conventional fluid challenge 3 hours