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

N/ACompletedNCT01194895

Shanghai Zhongshan Hospital101 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

101

Conditions

Acute Lung Injury

Interventions

protective ventilationOTHER

set tidal volume of 5ml/kg during one-lung ventilation

conventional ventilationOTHER

keep tidal volume at 8ml/kg during one-lung ventilation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

180 Fenglin Road

Shanghai, China

Outcomes

Primary Outcomes

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

Time frame: 10 minutes before surgery ,at the end of surgery immediately

Secondary Outcomes

postoperative hospital days

duration of hospital stay after surgery

Time frame: 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".

Time frame: 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

Time frame: after surgery up to 28 days

inhospital mortality

the number of death in the period of hospital stay

Time frame: after surgery up to 28 days

Oxygenation Index

Oxygenation Index=PaO2/FiO2

Time frame: 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

Time frame: 12 hours after the surgery

Data from ClinicalTrials.gov

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