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

Fudan University logo

Fudan University

Status

Completed

Conditions

Acute Lung Injury

Treatments

Other: conventional ventilation
Other: protective ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT01194895
ESOPV (Other Identifier)
ESO-2010-LV

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

101 participants in 2 patient groups

protective ventilation
Experimental group
Treatment:
Other: protective ventilation
conventional ventilation
Active Comparator group
Treatment:
Other: conventional ventilation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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