Clinical trial NCT01194895: A Trial to Evaluate the Impact of Lung-protective Intervention in Patients Undergoing Esophageal Cancer Surgery
Official title: Impact of Intraoperative Protective One-lung Ventilation in Patients Undergoing Esophagectomy : a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lung Injury
Keywords: esophagectomy
acute lung injury
protective ventilation
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2010-09-03
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: cytokines of bronchoalveolar lavage
timeFrame: 10 minutes before surgery ,at the end of surgery immediately
Secondary outcomes:
measure: postoperative hospital days
timeFrame: after surgery up to the time when patient is discharged or dead，it is an average
measure: incidence rate of acute lung injury
timeFrame: after surgery up to 28 days
measure: incidence rate of surgical complications
timeFrame: after surgery up to 28 days
measure: inhospital mortality
timeFrame: after surgery up to 28 days
measure: Oxygenation Index
timeFrame: 10 minutes before surgery,at the end of surgery immediately,12h after surgery
measure: CT scan of chest
timeFrame: 12 hours after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Zhanggang Xue, professor
role: STUDY_DIRECTOR
References:
citation: Shen Y, Zhong M, Wu W, Wang H, Feng M, Tan L, Wang Q. The impact of tidal volume on pulmonary complications following minimally invasive esophagectomy: a randomized and controlled study. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1267-73; discussion 1273-4. doi: 10.1016/j.jtcvs.2013.06.043. Epub 2013 Aug 28.