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Clinical Trials/NCT01194895
NCT01194895
Completed
Not Applicable

Impact of Intraoperative Protective One-lung Ventilation in Patients Undergoing Esophagectomy : a Prospective Randomized Controlled Trial

Shanghai Zhongshan Hospital1 site in 1 country101 target enrollmentAugust 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Lung Injury
Sponsor
Shanghai Zhongshan Hospital
Enrollment
101
Locations
1
Primary Endpoint
cytokines of bronchoalveolar lavage
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
March 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ming Zhong

department of anesthesiology and surgical intensive care unit

Shanghai Zhongshan Hospital

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • postoperative hospital days(after surgery up to the time when patient is discharged or dead,it is an average)
  • incidence rate of acute lung injury(after surgery up to 28 days)
  • incidence rate of surgical complications(after surgery up to 28 days)
  • inhospital mortality(after surgery up to 28 days)
  • Oxygenation Index(10 minutes before surgery,at the end of surgery immediately,12h after surgery)
  • CT scan of chest(12 hours after the surgery)

Study Sites (1)

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