Lung Cancer Clinical Trial
— OPEN THORUSOfficial title:
Ultrasound Assessment of Aeration Changes After Lung Lobectomy: a Pilot Study
The purpose of the study is to assess whether lung ultrasound is able to detect lung injury after lung resection surgery.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 31, 2021 |
Est. primary completion date | August 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 - ASA I-III - Non-small cell lung neoplasm - Elective lung lobectomy - Under one-lung ventilation Exclusion Criteria: - Pregnancy - Respiratory tract infection the previous month - Diagnosed pulmonary fibrosis - Predicted FEV < 40% - Surgery that includes resection of the thoracic wall or the diaphragm - Neoplasm metastasis - Obesity class II or more (BMI = 35 kg/m^2) - Risk of malnutrition CONUT > 1 - Hemoglobin < 10 g/dl - Chronic kidney failure: glomerular filtration < 60 ml/min/m^2, nephrectomy, kidney transplantation - Treatment with corticosteroids or immunosuppressive agents 3 months before surgery - Transfusion of blood products during the previous 10 days - Heart failure (New York Heart Association Functional Class 3 or 4) during the week before surgery. - Heart valve diseases over stage B of the American College of Cardiology/American - Heart Association Task Force on Practice Guidelines 2014 - Diastolic dysfunction |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital General Universitario de Valencia | Valencia |
Lead Sponsor | Collaborator |
---|---|
Hospital General Universitario de Valencia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in mLUSS after lung resection. | The modified lung ultrasound score (mLUSS) ranges 0-36; the higher the score, the less aeration (worse). | preoperative vs immediate postoperative period vs 24 hours after surgery. | |
Secondary | LUS feasibility in the dependent and non-dependent lung. | Percetage of patients in which ultrasound examination is feasible. There is no important surgical emphysema and/or the dressings or chest tubes do not preclude the feasibility of the examination. | Preoperative vs immediate postoperative period vs 24 hours after surgery. | |
Secondary | Changes in oxygenation (PAFI) after lung resection. | PAFI is the ratio between paO2 and fraction of inspired oxygen; the lower, the worse. | Preoperative vs immediate postoperative vs 24 hours after surgery. | |
Secondary | Changes in plasma cytokine IL-6 after lung resection. | Preoperative vs immediate postoperative vs 24 hours after surgery. | ||
Secondary | Changes in plasma cytokine IL-10 after lung resection. | Preoperative vs immediate postoperative vs 24 hours after surgery. | ||
Secondary | Changes in plasma TNFa after lung resection. | Preoperative vs immediate postoperative vs 24 hours after surgery. | ||
Secondary | Changes in blood bone natriuretic peptide (BNP) after lung resection. | Preoperative vs immediate postoperative vs 24 hours after surgery. |
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