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

Acute Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194895
• Other study ID #: ESO-2010-LV
• Secondary ID: ESOPV
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: March 13, 2013
• Start date: August 2010
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult

Intervention

Other:
• protective ventilation
set tidal volume of 5ml/kg during one-lung ventilation
• conventional ventilation
keep tidal volume at 8ml/kg during one-lung ventilation

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cytokines of bronchoalveolar lavage	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	10 minutes before surgery ,at the end of surgery immediately	Yes
Secondary	postoperative hospital days	duration of hospital stay after surgery	after surgery up to the time when patient is discharged or dead,it is an average	Yes
Secondary	incidence rate of acute lung injury	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".	after surgery up to 28 days	Yes
Secondary	incidence rate of surgical complications	surgical complications include anastomotic fistula, postoperative infection and the patients will be followed until death or discharged	after surgery up to 28 days	Yes
Secondary	inhospital mortality	the number of death in the period of hospital stay	after surgery up to 28 days	Yes
Secondary	Oxygenation Index	Oxygenation Index=PaO2/FiO2	10 minutes before surgery,at the end of surgery immediately,12h after surgery	Yes
Secondary	CT scan of chest	Severity of pulmonary edema will be evaluated by CT scan of chest	12 hours after the surgery	Yes