Driving Pressure Limited Ventilation During Video-assisted Thoracoscopic Lobectomy

Study Overview
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Brief Summary
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This study aims to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients undergoing one-lung ventilation during Video-assisted thoracoscopic lobectomy.

Detailed Description
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• More recently, the so-called lung-protective intraoperative ventilation strategies have been advocated to prevent lung injury. Such strategies aim at minimizing lung hyperinflation as well as cycling collapse and reopening of lung units, through the use of low tidal volumes (VTs) and positive end-expiratory pressure (PEEP). However, despite huge improvements in surgical and anesthesia techniques and management. It is surprising that, so far, mortality and pulmonary complication rates were not reduced over time .Recently, several investigations suggest an association between high driving pressure (the difference between the plateau pressure and the level of PEEP) and outcome for patients with acute respiratory distress syndrome. It is uncertain whether a similar association exists for high driving pressure during surgery and the occurrence of postoperative pulmonary complications. In this issue, Ary S Neto and colleagues report an individual patient data meta-analysis further investigating the risk of mechanical ventilation in healthy individuals during general anesthesia .After both a multivariate and mediation analysis, the driving pressure, but not the tidal volume or the positive end-expiratory pressure applied, seemed to be the only parameter that was associated with the development of postoperative pulmonary complications. This randomized controlled trial is aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.

Official Title
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A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy During Video-assisted Thoracoscopic Lobectomy

Conditions
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Pulmonary Complication, Thoracic Surgery

Intervention / Treatment
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* Procedure: Protective ventilation 1
* Procedure: Protective ventilation 2
* Procedure: Driving Pressure Limited Ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults greater than or equal to 18 years ARISCAT（Assess Respiratory Risk in Surgical Patients in Catalonia）≥26 points Patients undergoing video-assisted thoracoscopic lobectomy Exclusion Criteria: The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4 Emergency surgery Pulmonary hypertension Forced vital capacity or forced expiratory volume in 1 sec < 70% of the predicted values Coagulation disorder Pulmonary or extrapulmonary infections History of treatment with steroid in 3 months before surgery History of recurrent pneumothorax History of lung resection surgery History of mechanical ventilation in 2 weeks Body Mass Index[≥35 kg／m2 ] Patient who is contraindicated with application of positive end expiratory pressure

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Protective Ventilation 1<br>Intraoperatively ventilated patients with a tidal volume (VT) of 10 ml/kg of ideal body weight, the level of PEEP at 0 cmH2O and a FiO2 of100%. | Procedure: Protective ventilation 1<br>* Low tidal volume, high inspired oygen fraction (FiO2) and recruitment maneuver.<br>|
| Active Comparator: Protective Ventilation 2<br>Intraoperatively ventilated patients with a tidal volume (VT) of 6 ml/kg of ideal body weight, the level of PEEP at 5cmH2O and a FiO2 of 60% with lung recruitment maneuvers. | Procedure: Protective ventilation 2<br>* Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.<br>|
| Experimental: Driving Pressure Limited Ventilation<br>The intervention arm receives driving pressure limited ventilation during one-lung ventilation | Procedure: Driving Pressure Limited Ventilation<br>* Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 3 to 10 cmH2O during one-lung ventilation and a FiO2 of 60%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of postoperative pulmonary complications | Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale. | within the first 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial pressure of oxygen in arterial blood |  | 15 min after induction, 20 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery | 
| respiratory compliance | Dynamic compliance, Static compliance | during surgery | 
| TNF-α |  | the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation | 
| IL-8 |  | the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation | 
| ICU mortality |  | Patients will be followed during the period of hospital stay, an expected average of 28 days | 
| In-hospital mortality |  | Patients will be followed during the period of hospital stay, an expected average of 28 days | 
| 28-day survival |  | From day 0 to day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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driving pressure, one-lung ventilation