Influence of Moderate Inspired Oxygen Fraction (FiO2) and Protective Ventilation on Postoperative Pulmonary Complication

Study Overview
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Brief Summary
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The purpose of this study is to determine the influence of moderate FiO2 and the lung protective ventilation on postoperative pulmonary complications following hepatic resection surgery.

Conditions
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Hepatectomy

Intervention / Treatment
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* Other: Moderate FiO2 and Protective Lung Ventilation Using


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1 2,Planned intrabdominal hepatic resection surgery; Expected duration 2 hours to 6 hours; Age 40 yr to 70 yr); BMI 18-26.9kg/m2 Risk of postoperative pulmonary complications (Arozullah score ≥2); Exclusion Criteria: Noninvasive ventilation in the last 30 days; Recent history of pneumonia, ALI/ARDS (in the last 30 days); History of pulmonary resection; History of neuromuscular disease; Child-Pugh>A grade； Patient refusal;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: FiO2 80%,Nonprotective Lung Ventilation<br> | |
| Experimental: FiO2 30%,Nonprotective Lung Ventilation<br>FiO2 30%,Nonprotective Lung Ventilation | Other: Moderate FiO2 and Protective Lung Ventilation Using<br> <br> |
| Experimental: FiO2 80%,protective Lung Ventilation<br>FiO2 80% and protective Lung Ventilation | Other: Moderate FiO2 and Protective Lung Ventilation Using<br> <br> |
| Experimental: FiO2 30%,protective Lung Ventilation<br>FiO2 30% and protective Lung Ventilation | Other: Moderate FiO2 and Protective Lung Ventilation Using<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a composite of pulmonary and extrapulmonary complications occurring by day 7 after surgery. | The primary outcome was a composite of major pulmonary complications (defined as pneumonia or need for invasive or noninvasive ventilation for acute respiratory failure) and extrapulmonary complications (defined as sepsis, septic shock, or death) within the first 7 days after surgery. | during the first seven days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of pulmonary complications | the incidence of pulmonary complications due to any cause, graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications);extrapulmonary complications; durations of ICU and hospital stays; | within the 30-day follow-up period | 
| Oxidative stress markers | Oxidative stress markers variation in blood before anesthesia,during and after surgery , and compare with controls. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recruitment maneuvers, Moderate FiO2, Protective lung ventilation, Postoperative pulmonary complications, Positive end-expiratory pressure