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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01194895
Recruitment Status : Completed
First Posted : September 3, 2010
Last Update Posted : March 14, 2013
Information provided by (Responsible Party):
Ming Zhong, 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.

Condition or disease Intervention/treatment Phase
Acute Lung Injury Other: protective ventilation Other: conventional ventilation Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Intraoperative Protective One-lung Ventilation in Patients Undergoing Esophagectomy : a Prospective Randomized Controlled Trial
Study Start Date : August 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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".

  3. 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

  4. inhospital mortality [ Time Frame: after surgery up to 28 days ]
    the number of death in the period of hospital stay

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01194895

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

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 )
First Posted: September 3, 2010    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 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