GDT-PPV Protocol in Thoracic Surgery

Study Overview
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Brief Summary
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Peri-operative fluid-therapy is extremely important in thoracic surgery, because excessive administration of fluids during one-lung ventilation is correlated to an increasing risk of postoperative respiratory complications. Therefore, current guidelines on peri-operative management of patients undergoing thoracic surgery suggest a conservative fluid management strategy, based on intra-operative fluid loss replacement and maintenance of euvolemia. Nevertheless, intra-operative fluid loss estimation and consequently the correct infusion rate adoption are quite difficult to be addressed in clinical practice, and this often prevents the euvolemia maintenance in the peri-operative period. This limit claims the necessity to adopt new methods of fluid-therapy administration in thoracic surgery; among these the most promising is the Goal-Directed Therapy (GDT). GDT protocols based on Stroke Volume Variation (SVV) or Pulse Pressure Variation (PPV) monitoring have been adopted successfully in major and cardiac surgery but not yet in thoracic surgery. The aim of this randomized study is to evaluate the effects of a PPV-GDT fluid management protocol versus a conservative zero-balance protocol on intrapulmonary gas exchanges, in patients undergoing single-lung ventilation during thoracic surgery.

Detailed Description
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The intra-operative fluid-therapy (using lactated Ringer) will be based on pulse pressure variation (PPV group) with a target ≤5.8% or on compensation (1:1) of urine output (zero balance group). In both groups an intraoperative background infusion of lactated Ringer at 1-2 ml/kg/h will be administered.

Official Title
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Advantages of Pulse Pressure Variation (PPV) Monitoring in Thoracic Surgery

Conditions
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Thoracic Surgery, Fluid-therapy

Intervention / Treatment
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* Other: PPV-GDT
* Other: Zero-balance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients scheduled for Video-assisted thoracic surgery (VATS) lobectomy Exclusion Criteria: Patients who will not sign the informed consent Obesity (BMI > 35 kg/m2) Cardiovascular disease (heart failure, arrhythmia) OSAS requiring or not C-PAP therapy Chronic alcoholism intraoperative blod loss> 1500 ml One-lung ventilation duration< 60 min

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPV-GDT<br>Intra-operative fluid-therapy based (lactated Ringer) on continous PPV monitoring (target ≤5.8%) | Other: PPV-GDT<br>* fluid-therapy based on PPV monitoring<br>|
| Active Comparator: Zero balance<br>Intra-operative fluid-therapy (lactated Ringer) based on 1:1 compensation of urinary output | Other: Zero-balance<br>* fluid-therapy based on urinary output balance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 ratio | Ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fraction of inspired oxygen (FiO2) | 15 minutes after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pulmonary complications | e.g. Atelectasis, pneumonia, lung edema, pleural effusion, hypoxemia | Up to 3 days after surgery | 
| In-hospital stay | Hospital stay duration | Days until discharge, an average of 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulse pressure variation, zero balance, single-lung ventilation