Acute Lung Injury
Conditions
Keywords
esophagectomy, acute lung injury, protective ventilation
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.
Interventions
set tidal volume of 5ml/kg during one-lung ventilation
keep tidal volume at 8ml/kg during one-lung ventilation
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cytokines of bronchoalveolar lavage | 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
| Measure | Time frame | Description |
|---|---|---|
| incidence rate of acute lung injury | 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. |
| incidence rate of surgical complications | after surgery up to 28 days | surgical complications include anastomotic fistula, postoperative infection and the patients will be followed until death or discharged |
| postoperative hospital days | after surgery up to the time when patient is discharged or dead，it is an average | duration of hospital stay after surgery |
| Oxygenation Index | 10 minutes before surgery,at the end of surgery immediately,12h after surgery | Oxygenation Index=PaO2/FiO2 |
| CT scan of chest | 12 hours after the surgery | Severity of pulmonary edema will be evaluated by CT scan of chest |
| inhospital mortality | after surgery up to 28 days | the number of death in the period of hospital stay |
Countries
China
Outcome results
None listed