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
2 other identifiers
interventional
101
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 18, 2010
CompletedFirst Posted
Study publicly available on registry
September 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 14, 2013
March 1, 2013
2.4 years
August 18, 2010
March 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
postoperative hospital days
after surgery up to the time when patient is discharged or dead，it is an average
incidence rate of acute lung injury
after surgery up to 28 days
incidence rate of surgical complications
after surgery up to 28 days
inhospital mortality
after surgery up to 28 days
Oxygenation Index
10 minutes before surgery,at the end of surgery immediately,12h after surgery
- +1 more secondary outcomes
Study Arms (2)
protective ventilation
EXPERIMENTALconventional ventilation
ACTIVE COMPARATORInterventions
set tidal volume of 5ml/kg during one-lung ventilation
keep tidal volume at 8ml/kg during one-lung ventilation
Eligibility Criteria
You may qualify if:
- clinical diagnosis of esophageal carcinoma and planned for esophagectomy
- indication for one-lung ventilation
- informed consent
- ASA I\~II
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
180 Fenglin Road
Shanghai, 20032, China
Related Publications (1)
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.
PMID: 23993028DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhanggang Xue, professor
Shanghai Zhongshan Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- department of anesthesiology and surgical intensive care unit
Study Record Dates
First Submitted
August 18, 2010
First Posted
September 3, 2010
Study Start
August 1, 2010
Primary Completion
January 1, 2013
Study Completion
March 1, 2013
Last Updated
March 14, 2013
Record last verified: 2013-03