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

This study has been completed.
Information provided by (Responsible Party):
Ming Zhong, Shanghai Zhongshan Hospital Identifier:
First received: August 18, 2010
Last updated: March 13, 2013
Last verified: March 2013
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.

Condition Intervention
Acute Lung Injury Other: protective ventilation Other: conventional ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Intraoperative Protective One-lung Ventilation in Patients Undergoing Esophagectomy : a Prospective Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Ming Zhong, Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • cytokines of bronchoalveolar lavage [ Time Frame: 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:
  • postoperative hospital days [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: after surgery up to 28 days ]
    the number of death in the period of hospital stay

  • Oxygenation Index [ Time Frame: 10 minutes before surgery,at the end of surgery immediately,12h after surgery ]
    Oxygenation Index=PaO2/FiO2

  • CT scan of chest [ Time Frame: 12 hours after the surgery ]
    Severity of pulmonary edema will be evaluated by CT scan of chest

Enrollment: 101
Study Start Date: August 2010
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: protective ventilation Other: protective ventilation
set tidal volume of 5ml/kg during one-lung ventilation
Other Name: low tidal volume ventilation
Active Comparator: conventional ventilation Other: conventional ventilation
keep tidal volume at 8ml/kg during one-lung ventilation
Other Name: normal tidal volume ventilation

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • clinical diagnosis of esophageal carcinoma and planned for esophagectomy
  • indication for one-lung ventilation
  • informed consent
  • ASA I~II

Exclusion Criteria:

  • 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
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Please refer to this study by its identifier: NCT01194895

180 Fenglin Road
Shanghai, China, 20032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Study Director: Zhanggang Xue, professor Shanghai Zhongshan Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ming Zhong, department of anesthesiology and surgical intensive care unit, Shanghai Zhongshan Hospital Identifier: NCT01194895     History of Changes
Other Study ID Numbers: ESO-2010-LV
ESOPV ( Other Identifier: SICU )
Study First Received: August 18, 2010
Last Updated: March 13, 2013

Keywords provided by Ming Zhong, Shanghai Zhongshan Hospital:
acute lung injury
protective ventilation

Additional relevant MeSH terms:
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders processed this record on July 21, 2017