Back to resultsA Trial to Evaluate the Impact of Lung-protective Intervention in Patients Undergoing Esophageal Cancer Surgery
Primary Purpose
Acute Lung Injury
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
protective ventilation
conventional ventilation
Sponsored by
About this trial
This is an interventional prevention trial for Acute Lung Injury focused on measuring esophagectomy, acute lung injury, protective ventilation
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
Sites / Locations
- 180 Fenglin Road
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
protective ventilation
conventional ventilation
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
postoperative hospital days
duration of hospital stay after surgery
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".
incidence rate of surgical complications
surgical complications include anastomotic fistula, postoperative infection and the patients will be followed until death or discharged
inhospital mortality
the number of death in the period of hospital stay
Oxygenation Index
Oxygenation Index=PaO2/FiO2
CT scan of chest
Severity of pulmonary edema will be evaluated by CT scan of chest
Full Information
NCT ID
NCT01194895
First Posted
August 18, 2010
Last Updated
March 13, 2013
Sponsor
Shanghai Zhongshan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01194895
Brief Title
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
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
esophagectomy, acute lung injury, protective ventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
protective ventilation
Arm Type
Experimental
Arm Title
conventional ventilation
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
protective ventilation
Other Intervention Name(s)
low tidal volume ventilation
Intervention Description
set tidal volume of 5ml/kg during one-lung ventilation
Intervention Type
Other
Intervention Name(s)
conventional ventilation
Other Intervention Name(s)
normal tidal volume ventilation
Intervention Description
keep tidal volume at 8ml/kg during one-lung ventilation
Primary Outcome Measure Information:
Title
cytokines of bronchoalveolar lavage
Description
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
Time Frame
10 minutes before surgery ,at the end of surgery immediately
Secondary Outcome Measure Information:
Title
postoperative hospital days
Description
duration of hospital stay after surgery
Time Frame
after surgery up to the time when patient is discharged or dead，it is an average
Title
incidence rate of acute lung injury
Description
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".
Time Frame
after surgery up to 28 days
Title
incidence rate of surgical complications
Description
surgical complications include anastomotic fistula, postoperative infection and the patients will be followed until death or discharged
Time Frame
after surgery up to 28 days
Title
inhospital mortality
Description
the number of death in the period of hospital stay
Time Frame
after surgery up to 28 days
Title
Oxygenation Index
Description
Oxygenation Index=PaO2/FiO2
Time Frame
10 minutes before surgery,at the end of surgery immediately,12h after surgery
Title
CT scan of chest
Description
Severity of pulmonary edema will be evaluated by CT scan of chest
Time Frame
12 hours after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanggang Xue, professor
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
180 Fenglin Road
City
Shanghai
ZIP/Postal Code
20032
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
23993028
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. Erratum In: J Thorac Cardiovasc Surg. 2014 Jan;147(1):544.
Results Reference
derived
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A Trial to Evaluate the Impact of Lung-protective Intervention in Patients Undergoing Esophageal Cancer Surgery
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