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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Lung Injury
• Intervention / Treatment: Other: protective ventilation; Other: conventional ventilation

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 20032
    • 180 Fenglin Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: protective ventilation	Other: protective ventilation; set tidal volume of 5ml/kg during one-lung ventilation; Other Names: low tidal volume ventilation
ACTIVE_COMPARATOR: conventional ventilation	Other: conventional ventilation; keep tidal volume at 8ml/kg during one-lung ventilation; Other Names: normal tidal volume ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inhospital mortality	the number of death in the period of hospital stay	after surgery up to 28 days
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
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
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
Oxygenation Index	Oxygenation Index=PaO2/FiO2	10 minutes before surgery,at the end of surgery immediately,12h after surgery
CT scan of chest	Severity of pulmonary edema will be evaluated by CT scan of chest	12 hours after the surgery

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Director: Zhanggang Xue, professor, Shanghai Zhongshan Hospital

Publications and helpful links

General Publications

• 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. Erratum In: J Thorac Cardiovasc Surg. 2014 Jan;147(1):544.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): March 1, 2013

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: September 2, 2010
• First Posted (ESTIMATE): September 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 14, 2013
• Last Update Submitted That Met QC Criteria: March 13, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: acute lung injury; esophagectomy; protective ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: ESO-2010-LV; ESOPV (OTHER: SICU)