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


N/A
18 Years
80 Years
Not Enrolling
Both
Acute Lung Injury

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

cytokines of bronchoalveolar lavage

Outcome Description:

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

Outcome Time Frame:

10 minutes before surgery ,at the end of surgery immediately

Safety Issue:

Yes

Principal Investigator

Zhanggang Xue, professor

Investigator Role:

Study Director

Investigator Affiliation:

Shanghai Zhongshan Hospital

Authority:

China: Ministry of Health

Study ID:

ESO-2010-LV

NCT ID:

NCT01194895

Start Date:

August 2010

Completion Date:

March 2013

Related Keywords:

  • Acute Lung Injury
  • esophagectomy
  • acute lung injury
  • protective ventilation
  • Esophageal Neoplasms
  • Acute Lung Injury
  • Respiratory Distress Syndrome, Adult
  • Lung Injury

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