Inflammation Clinical Trial
Official title:
The Effect of Recruitment Maneuver With Protective Ventilation on the Pulmonary and Systemic Inflammatory Response to One-lung Ventilation
Verified date | June 2012 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 20 Years and older - Patients undergoing thoracic surgery Exclusion Criteria: - Emergency surgery - Heart failure - Pulmonary hypertension - Forced vital capacity or forced expiratory volume in 1 sec < 50% of the predicted values - Coagulation disorder - Pulmonary or extrapulmonary infections - History of treatment with steroid in 3 months before surgery - History of recurrent pneumothorax - History of lung resection surgery |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Levels of IL-8, TNFa in the bronchoalveolar lavage | up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery | No | |
Secondary | Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage | up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery | No | |
Secondary | plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa | up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery | No | |
Secondary | oxygenation | Changes in PaO2/FIO2 ratio | 1 hour after extubation | No |
Secondary | Chest-X ray | 7 days after surgery | Yes |
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