A Trial to Evaluate the Impact of Lung-protective Intervention in Patients Undergoing Esophageal Cancer Surgery

Study Overview
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Brief Summary
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The purpose of this trial is to determine whether low tidal volume during intraoperative one-lung ventilation could decrease the incidence rate of postoperative acute lung injury compared to normal tidal volume.

Detailed Description
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Large tidal volume are known risk factor of acute lung injury.Mechanical ventilation with low tidal volume has been shown to attenuate lung injuries in critically ill patients.Esophagectomy surgery need a relatively long time of one-lung ventilation. A normal tidal volume of two-lung ventilation should be a large one when exerted to one lung. We hypothesized that low tidal volume ventilation during one-lung ventilation could decrease incidence rate of postoperative acute lung injury and mortality.

Official Title
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Impact of Intraoperative Protective One-lung Ventilation in Patients Undergoing Esophagectomy : a Prospective Randomized Controlled Trial

Conditions
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Acute Lung Injury

Intervention / Treatment
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* Other: protective ventilation
* Other: conventional ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of esophageal carcinoma and planned for esophagectomy indication for one-lung ventilation informed consent ASA I II Exclusion Criteria: NYHA III IV severe COPD pulmonary fibrosis any new pulmonary infiltrate on chest radiograph preoperative acute infection suspected altered liver function( Child-Pugh class B or moe) acute or chronic renal failure preoperative corticosteroid treatment during month before inclusion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: protective ventilation<br> | Other: protective ventilation<br>* set tidal volume of 5ml/kg during one-lung ventilation<br>* Other names: low tidal volume ventilation;|
| Active Comparator: conventional ventilation<br> | Other: conventional ventilation<br>* keep tidal volume at 8ml/kg during one-lung ventilation<br>* Other names: normal tidal volume ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokines of bronchoalveolar lavage | TNF-a,IL-1b,IL-6,IL-8 of BAL will be measured with enzyme-linked immunoassay,all markers will be reported with a unit of pg/ml | 10 minutes before surgery ,at the end of surgery immediately | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative hospital days | duration of hospital stay after surgery | after surgery up to the time when patient is discharged or dead，it is an average | 
| incidence rate of acute lung injury | Diagnosis of acute lung injury is followed the consensus criteria for ALI/ARDS published in Am J Respir Crit Care Med 1994, 149:818-824. | after surgery up to 28 days | 
| incidence rate of surgical complications | surgical complications include anastomotic fistula, postoperative infection and the patients will be followed until death or discharged | after surgery up to 28 days | 
| inhospital mortality | the number of death in the period of hospital stay | after surgery up to 28 days | 
| Oxygenation Index | Oxygenation Index=PaO2/FiO2 | 10 minutes before surgery,at the end of surgery immediately,12h after surgery | 
| CT scan of chest | Severity of pulmonary edema will be evaluated by CT scan of chest | 12 hours after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophagectomy, acute lung injury, protective ventilation