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Completed

NCT Number: NCT04677309

Lung Ultrasound to Assess Aeration Loss After Lung Resection Surgery

The purpose of this prospective observational study is to assess perioperative changes in lung aeration after lung resection surgery using lung ultrasound, and to explore their relationship with oxygenation, inflammatory biomarkers, cardiac stress markers and diaphragmatic function.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perioperative lung ultrasound assessment

Diagnostic Test

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

    Description of lung ultrasound findings and lung aeration loss in each lung region at the predefined perioperative time points.

  2. Changes in oxygenation after lung resection surgery

    Time frame: preoperative vs immediate postoperative vs 24 hours after surgery

    Oxygenation will be assessed using the PaO₂/FiO₂ ratio at the predefined perioperative time points.

  3. Changes in plasma inflammatory biomarkers after lung resection surgery

    Time frame: preoperative vs immediate postoperative vs 24 hours after surgery

    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.

  4. Changes in cardiac stress markers after lung resection surgery

    Time frame: preoperative vs immediate postoperative vs 24 hours after surgery

    NT-proBNP values will be assessed at the predefined perioperative time points and explored in relation to lung ultrasound findings.

  5. Changes in diaphragmatic function after lung resection surgery

    Time frame: preoperative vs immediate postoperative vs 24 hours after surgery

    Diaphragmatic function will be assessed by ultrasound using diaphragmatic thickening fraction at the predefined perioperative time points.

Sponsors and collaborators

Lead sponsor

Ana Broseta Lleó

Other

Collaborators

  • Hospital General Universitario de Valencia

Registry information

Official study title

Lung Ultrasound Assessment of Aeration Changes After Lung Resection Surgery: A Pilot Study

Acronym: THORUS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2020
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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