Hospital General Universitario de Valencia
Valencia, 46014, Spain
NCT Number: NCT04677309
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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Notify Me18 year and older
All sexes
Observational
Valencia, 46014, Spain
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.
Healthy volunteers accepted: No
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Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
Ana Broseta Lleó
Other
Lung Ultrasound Assessment of Aeration Changes After Lung Resection Surgery: A Pilot Study
Acronym: THORUS
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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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