Clinical trial · Interventional
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
NCT01194895CI-TRIAL-00009724completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lung Injury | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional ventilation | Other | — | UNRESOLVED |
| protective ventilation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- protective ventilation
- interventionNames
- Other: protective ventilation
- type
- ACTIVE_COMPARATOR
- label
- conventional ventilation
- interventionNames
- Other: conventional ventilation
Primary outcomes (1)
- measure
- cytokines of bronchoalveolar lavage
- timeFrame
- 10 minutes before surgery ,at the end of surgery immediately
- 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
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDShen 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 23993028