Lung Ultrasound to Assess Aeration Loss After Lung Resection Surgery (THORUS)
Lung Ultrasound Assessment of Aeration Changes After Lung Resection Surgery: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pulmonary complications are common after lung resection surgery and are associated with worse clinical outcomes. Lung ultrasound (LUS) is a bedside, non-invasive and repeatable imaging technique that can detect regional changes in lung aeration. These changes may reflect postoperative loss of aeration related to one-lung ventilation, surgical manipulation, lung collapse and re-expansion, inflammatory response, diaphragmatic dysfunction or other perioperative mechanisms.
This is a prospective, single-centre, observational pilot study including consecutive adult patients scheduled for elective lung resection surgery under one-lung ventilation. Lung ultrasound was performed at three predefined time points: before surgery (T1), 30 minutes after extubation (T2), and 24 hours after surgery (T3). Each hemithorax was divided into six regions: anterior, lateral and posterior areas, each subdivided into upper and lower zones. For each examination, the most pathological ultrasound finding in each area was recorded. A semiquantitative lung ultrasound score was calculated to assess lung aeration over time, both globally and separately for the operated and non-operated lung. Corrected LUSS values were used to compensate for the loss of areas after surgery.
At the same predefined time points, oxygenation, NT-proBNP and plasma inflammatory biomarkers, including IL-6, IL-10 and TNF-α, were assessed. Bedside transthoracic echocardiography and diaphragmatic ultrasound were also performed as exploratory analyses to evaluate possible cardiovascular and diaphragmatic mechanisms associated with postoperative loss of lung aeration.
The primary objective of the study is to assess perioperative changes in lung aeration after lung resection surgery using LUS. Secondary objectives are to describe the regional distribution of LUS findings, compare the operated and non-operated lung, assess the feasibility of repeated perioperative LUS examinations, and explore the relationship between LUS changes and oxygenation, inflammatory biomarkers, cardiac stress markers and diaphragmatic function.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Valencia
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Valencia, Valencia, Spain, 46014
- Hospital General Universitario de Valencia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18
- ASA I-III
- Non-small cell lung neoplasm
- Elective lobectomy
- Under one-lung ventilation
Exclusion Criteria:
- pregnancy
- 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 score > 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
- Previously documented elevated left atrial pressure or cardiac disease associated with elevated left-sided filling pressures.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Lung resection surgery
Adult patients scheduled for elective lobectomy surgery under one-lung ventilation in a tertiary referral hospital.
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Lung ultrasound was performed at three predefined perioperative time points: before surgery, in the immediate postoperative period after extubation, and 24 hours after surgery.
Each hemithorax was assessed in six regions, and lung aeration was evaluated using a semiquantitative lung ultrasound score.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in lung aeration after lung resection surgery assessed by lung ultrasound score
Time Frame: preoperative vs immediate postoperative period vs 24 hours after surgery
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The lung ultrasound score is a semiquantitative score used to assess lung aeration.
Higher values indicate greater loss of aeration.
Changes will be assessed between the preoperative period, the immediate postoperative period after extubation, and 24 hours after surgery.
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preoperative vs immediate postoperative period vs 24 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Regional distribution of lung ultrasound findings in the operated and non-operated lung
Time Frame: preoperative vs immediate postoperative period vs 24 hours after surgery
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Description of lung ultrasound findings and lung aeration loss in each lung region at the predefined perioperative time points.
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preoperative vs immediate postoperative period vs 24 hours after surgery
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Changes in oxygenation after lung resection surgery
Time Frame: preoperative vs immediate postoperative vs 24 hours after surgery
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Oxygenation will be assessed using the PaO₂/FiO₂ ratio at the predefined perioperative time points.
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preoperative vs immediate postoperative vs 24 hours after surgery
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Changes in plasma inflammatory biomarkers after lung resection surgery
Time Frame: preoperative vs immediate postoperative vs 24 hours after surgery
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Plasma IL-6, IL-10 and TNF-α concentrations, and the IL-6/IL-10 ratio, will be assessed at the predefined perioperative time points.
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preoperative vs immediate postoperative vs 24 hours after surgery
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Changes in cardiac stress markers after lung resection surgery
Time Frame: preoperative vs immediate postoperative vs 24 hours after surgery
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NT-proBNP values will be assessed at the predefined perioperative time points and explored in relation to lung ultrasound findings.
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preoperative vs immediate postoperative vs 24 hours after surgery
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Changes in diaphragmatic function after lung resection surgery
Time Frame: preoperative vs immediate postoperative vs 24 hours after surgery
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Diaphragmatic function will be assessed by ultrasound using diaphragmatic thickening fraction at the predefined perioperative time points.
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preoperative vs immediate postoperative vs 24 hours after surgery
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ana Broseta Lleó, Consultant, Hospital General Universitario de Valencia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- THORUS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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