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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.
Sponsor:
Information provided by (Responsible Party):
Ming Zhong, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01194895
First received: August 18, 2010
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • cytokines of bronchoalveolar lavage [ Time Frame: 10 minutes before surgery ,at the end of surgery immediately ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    duration of hospital stay after surgery

  • incidence rate of acute lung injury [ Time Frame: after surgery up to 28 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Oxygenation Index=PaO2/FiO2

  • CT scan of chest [ Time Frame: 12 hours after the surgery ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194895

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

No publications provided

Responsible Party: Ming Zhong, department of anesthesiology and surgical intensive care unit, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01194895     History of Changes
Other Study ID Numbers: ESO-2010-LV, ESOPV
Study First Received: August 18, 2010
Last Updated: March 13, 2013
Health Authority: China: Ministry of Health

Keywords provided by Shanghai Zhongshan Hospital:
esophagectomy
acute lung injury
protective ventilation

Additional relevant MeSH terms:
Esophageal Neoplasms
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Injury
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
 Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013