Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection

NCT ID: NCT03237351

Last Updated: 2020-04-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2020-03-01

Brief Summary

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Perioperative fluid management is a key component of anesthetic management during thoracic surgery. On one hand, fluid restriction could compromise perfusion of vital organs and surgical anastomosis. On the other hand, fluid overload could lead to cardiopulmonary complications, notably pulmonary edema, which carries a high mortality rate. Perioperative fluid management to avoid postpneumonectomy pulmonary edema has been previously reviewed. Therefore, to achieve the balance between preventing fluid overload and optimising organ perfusion, the practical index to guide fluid management, which can predict whether fluid loading will improve haemodynamic conditions in an individual patient, would be very valuable during lung surgery. Perioperative goal-directed fluid therapy (GDFT) is a cornerstone of tissue perfusion and oxygenation, and it can improve surgical outcomes. Respiratory variations of arterial pressure \[i.e. pulse pressure variation (PPV) and systolic pressure variation\] can predict fluid responsiveness in mechanically ventilated patients under various conditions. Therefore, pressure variations are increasingly being advocated for fluid management.This study will discuss the effects of pulse pressure variation(PPV) in different level during anesthesia on patients with oxygenation index and short-term prognosis undergoing video-assisted thoracoscopic surgery for pneumoresection.

Detailed Description

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Conditions

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Goal-directed Fluid Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional therapy group

Patients in Conventional therapy group were received fluid therapy: intraoperative transfusion volume=maintenance fluids+deficit replacement+restoration of losses and with heart rate, mean arterial pressure, urine measurement ect.

Group Type ACTIVE_COMPARATOR

Fluid therapy

Intervention Type DEVICE

Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.

Low value of PPV group

Patients in low value of PPV group were received fluid therapy according to PPV (3% ≤PPV \< 5%) .

Group Type EXPERIMENTAL

Fluid therapy

Intervention Type DEVICE

Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.

High value of PPV group

Patients in high value of PPV group were received fluid therapy according to PPV (5% ≤PPV \< 8%) .

Group Type EXPERIMENTAL

Fluid therapy

Intervention Type DEVICE

Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.

Interventions

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Fluid therapy

Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists physical status I-III; aged 18-60 years old; BMI 18.5 \~ 28 kg/m2

Exclusion Criteria

* Refused to participate in the experiment, hepatic/renal/cardiac dysfunction, severe valvular disease, frequent arrhythmia, moderate anemia and severe electrolyte disturbance before operation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZhiHeng Liu

OTHER

Sponsor Role lead

Responsible Party

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ZhiHeng Liu

Chair of Department of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Site Status

Countries

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China

References

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Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.

Reference Type BACKGROUND
PMID: 19837807 (View on PubMed)

Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.

Reference Type BACKGROUND
PMID: 19602972 (View on PubMed)

Ripolles-Melchor J, Espinosa A, Martinez-Hurtado E, Abad-Gurumeta A, Casans-Frances R, Fernandez-Perez C, Lopez-Timoneda F, Calvo-Vecino JM. Perioperative goal-directed hemodynamic therapy in noncardiac surgery: a systematic review and meta-analysis. J Clin Anesth. 2016 Feb;28:105-15. doi: 10.1016/j.jclinane.2015.08.004. Epub 2015 Oct 2.

Reference Type BACKGROUND
PMID: 26440438 (View on PubMed)

Chau EH, Slinger P. Perioperative fluid management for pulmonary resection surgery and esophagectomy. Semin Cardiothorac Vasc Anesth. 2014 Mar;18(1):36-44. doi: 10.1177/1089253213491014. Epub 2013 May 29.

Reference Type BACKGROUND
PMID: 23719773 (View on PubMed)

Zhang J, Chen CQ, Lei XZ, Feng ZY, Zhu SM. Goal-directed fluid optimization based on stroke volume variation and cardiac index during one-lung ventilation in patients undergoing thoracoscopy lobectomy operations: a pilot study. Clinics (Sao Paulo). 2013 Jul;68(7):1065-70. doi: 10.6061/clinics/2013(07)27.

Reference Type BACKGROUND
PMID: 23917675 (View on PubMed)

Lee JH, Jeon Y, Bahk JH, Gil NS, Hong DM, Kim JH, Kim HJ. Pulse pressure variation as a predictor of fluid responsiveness during one-lung ventilation for lung surgery using thoracotomy: randomised controlled study. Eur J Anaesthesiol. 2011 Jan;28(1):39-44. doi: 10.1097/EJA.0b013e32834089cf.

Reference Type BACKGROUND
PMID: 21088596 (View on PubMed)

Other Identifiers

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2017041102

Identifier Type: -

Identifier Source: org_study_id

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