Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection

April 21, 2020 updated by: ZhiHeng Liu

Goal Directed Fluid Therapy Guided Fluid Management in Pneumoresection: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518035
        • Shenzhen Second People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: 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.
Experimental: Low value of PPV group
Patients in low value of PPV group were received fluid therapy according to PPV (3% ≤PPV < 5%) .
Device: 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.
Experimental: High value of PPV group
Patients in high value of PPV group were received fluid therapy according to PPV (5% ≤PPV < 8%) .
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline Oxygenation Index in 48 hours
Time Frame: Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation
Before induction, 5 minutes before the end of one-lung ventilation, 48 hours after the operation

Secondary Outcome Measures

Outcome Measure
Time Frame
The duration of surgery
Time Frame: During surgery period
During surgery period
The duration of mechanical ventilation
Time Frame: During surgery period
During surgery period
Crystalloid administered
Time Frame: During surgery period
During surgery period
Colloid administered
Time Frame: During surgery period
During surgery period
Blood loss
Time Frame: During surgery period
During surgery period
Urine output
Time Frame: During surgery period
During surgery period
Number of patients received vasopressor
Time Frame: During surgery period
During surgery period
Blood pressure
Time Frame: Before the surgery and 48 hours after surgery
Before the surgery and 48 hours after surgery
Leukocyte
Time Frame: Before the surgery and 48 hours after surgery
Before the surgery and 48 hours after surgery
Hematocrit
Time Frame: Before the surgery and 48 hours after surgery
Before the surgery and 48 hours after surgery
Complication until hospital discharge
Time Frame: 1 month after surgery
1 month after surgery
Hospital stay postoperatively
Time Frame: 1 month after surgery
1 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZhiHeng Liu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 30, 2017

First Posted (Actual)

August 2, 2017

Study Record Updates

Last Update Posted (Actual)

April 22, 2020

Last Update Submitted That Met QC Criteria

April 21, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017041102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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