Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
28 participants
OBSERVATIONAL
2020-12-20
2023-04-30
Brief Summary
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Detailed Description
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This is a prospective, single-centre, observational study in which 28 consecutive participants with non-small cell lung cancer scheduled for lobectomy will be recruited. Participants will be divided in two groups depending on the surgical approach. First group will be lobectomy via thoracotomy. Second group will be lobectomy via VATS. Participants will be recruited consecutively until there are 14 patients in each group. LUS will be performed in each participant's dependent and non-dependent lung at three predefined time points: before surgery, after extubation and 24 h after surgery. Each hemithorax will be divided into 6 areas: anterior, lateral and posterior, separated by the anterior and posterior axillary lines, each divided into upper and lower zones. For each echographic examination, cineloops of the most pathological findings in each area will be stored and analysed offline by two independent and blinded anesthesiologists. From these, a semiquantitative score, the modified lung ultrasound score (mLUSS), will be calculated for each hemithorax to assess lung aeration at each time point. The level of agreement for mLUSS will be tested. At the same predefined time points blood plasma samples will be collected, flash-frozen and stored in order to measure levels of the inflammatory mediators IL-6, IL-10 and TNFα.
The invertigators hypothesise that LUS can detect lung injury after lung resection surgery. The primary objective of the study is to assess changes in lung aeration after lung resection with mLUSS. Secondary objectives are, first, to describe LUS findings after lung resection surgery, second, to assess the ability of mLUSS to detect oxygenation changes after lung resection and third, to compare the behaviour of inflammatory mediators in plasma with mLUSS changes.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lung resection less than lobectomy
participants scheduled for lung resection that is less than lobectomy
No interventions assigned to this group
Lung resection equal to or greater than lobectomy
participants scheduled for lung resection that is equal to or greater than lobectomy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* ASA I-III
* Non-small cell lung neoplasm
* Elective lung resection
* Via VATS
* Under one-lung ventilation
Exclusion Criteria
* Diagnosed pulmonary fibrosis
* Scheduled surgery limited to biopsy
* Surgery that includes resection of the thoracic wall or the diaphragm
* Predicted FEV1 \< 40%
* 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
18 Years
ALL
No
Sponsors
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Hospital General Universitario de Valencia
OTHER
Ana Broseta Lleó
OTHER
Responsible Party
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Ana Broseta Lleó
Consultant in Anesthesiology
Principal Investigators
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Ana Broseta Lleó, Consultant
Role: PRINCIPAL_INVESTIGATOR
Hospital General Universitario de Valencia
Locations
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Hospital General Universitario de Valencia
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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THORUS
Identifier Type: -
Identifier Source: org_study_id
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