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Completed

NCT Number: NCT01194895

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

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.

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Key information

Conditions

Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

180 Fenglin Road

Shanghai, 20032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROTECTIVE VENTILATION

Other

set tidal volume of 5ml/kg during one-lung ventilation

Other names: low tidal volume ventilation

Conventional ventilation

Other

keep tidal volume at 8ml/kg during one-lung ventilation

Other names: normal tidal volume ventilation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 3, 2010
Registry last updated
Mar 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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