Lung Protective Ventilation During Pulmonary Lobectomy in Children

Study Overview
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Brief Summary
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The investigator will evaluate the influence of lung protective ventilation on postoperative clinical outcome in pediatric patients. The hypothesis is that application of low tidal volume, intermittent alveolar recruitment and adequate positive end-expiratory pressure (PEEP) would be more beneficial than conventional ventilation in children.

Official Title
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The Influence of Lung Protective Ventilation During Pulmonary Lobectomy on Clinical Outcome in Pediatric Patients

Conditions
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Pulmonary Complication

Intervention / Treatment
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* Procedure: lung protective ventilation
* Procedure: Conventional ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children who are scheduled for lung lobectomy under general anesthesia ASA physical status I, II Exclusion Criteria: History of airway or pulmonary interstitial disease Active URI Systemic inflammatory response disease cardiac disease

Ages Eligible for Study
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Maximum Age: 5 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Conventional ventilation group<br>Mechanical ventilation is maintained with tidal volume (TV) of 10 ml/kg without PEEP during two-lung ventilation and TV of 8 ml/kg without PEEP during one-lung ventilation. Alveolar recruitment is performed 3 times; after intubation, before one-lung ventilation and after lung resection. | Procedure: Conventional ventilation<br>* TV 8 ml/kg during one lung ventilation and 10 ml/kg during two-lung ventilation without PEEP<br>|
| Active Comparator: Lung protective ventilation group<br>Mechanical ventilation is maintained with tidal volume (TV) of 6 ml/kg with PEEP 6 cmH2O during two-lung ventilation and TV of 4 ml/kg PEEP 6 cmH2O during one-lung ventilation. Alveolar recruitment is performed 3 times; after intubation, before one-lung ventilation and after lung resection. | Procedure: lung protective ventilation<br>* TV 4 ml/kg during one lung ventilation and 6 ml/kg during two-lung ventilation with PEEP of 6 cmH2O<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with pulmonary complication | The number of patients with pulmonary complication including atelectasis, pulmonary infiltration, pulmonary edema, pulmonary infection, pleural effusion and pulmonary embolism | up to postoperative 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients with desaturation | The number of patients with desaturation (SpO2 < 90%) | During surgery | 
| The number of patients with extrapulmonary complication |  | through study completion, an average of 1 year | 
| Mean duration of mechanical ventilation |  | through study completion, an average of 1 year | 
| Mean duration of ICU stay |  | through study completion, an average of 1 year |