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

Not Applicable

Completed

• Conditions: Acute Lung Injury
• Interventions: Other: conventional ventilation; Other: protective ventilation

• Registration Number: NCT01194895
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Primary Completion: 2013-01
• Status Verified: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional ventilation	conventional ventilation	-
protective ventilation	protective ventilation	-

Primary Outcome Measures

Name	Time	Method
cytokines of bronchoalveolar lavage	10 minutes before surgery ,at the end of surgery immediately	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

Secondary Outcome Measures

Name	Time	Method
postoperative hospital days	after surgery up to the time when patient is discharged or dead，it is an average	duration of hospital stay after surgery
incidence rate of acute lung injury	after surgery up to 28 days	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".
incidence rate of surgical complications	after surgery up to 28 days	surgical complications include anastomotic fistula, postoperative infection and the patients will be followed until death or discharged
inhospital mortality	after surgery up to 28 days	the number of death in the period of hospital stay
Oxygenation Index	10 minutes before surgery,at the end of surgery immediately,12h after surgery	Oxygenation Index=PaO2/FiO2
CT scan of chest	12 hours after the surgery	Severity of pulmonary edema will be evaluated by CT scan of chest

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, China