Lung NeoplasmTHORUSNCT04677309
Lung Ultrasound to Assess Aeration Loss After Lung Resection Surgery
An observational study of Lung Neoplasm and Lung Cancer, run by Ana Broseta Lleó at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm, Lung Cancer, Lung Resection Surgery
- What is being tested?
- Perioperative lung ultrasound assessment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 20 Dec 2020to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective lung resection surgery at a tertiary referral hospital.
Who may be able to join
- Age > 18
- ASA I-III
- Non-small cell lung neoplasm
- Elective lobectomy
- Under one-lung ventilation
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
About this study
Official title: Lung Ultrasound Assessment of Aeration Changes After Lung Resection Surgery: A Pilot Study
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.
Read the 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.
- Conditions
- Lung Neoplasm, Lung Cancer, Lung Resection Surgery, Thoracic Surgery, One-lung Ventilation (OLV), Postoperative Pulmonary Complications (PPCs)
- Being tested
- Perioperative lung ultrasound assessment
- Keywords
- thoracic surgery, lung ultrasound, lung aeration, lung ultrasound score, lung resection, lobectomy, one-lung ventilation, postoperative pulmonary complications, oxygenation, cytokines, NT-proBNP, diaphragmatic function
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative lung ultrasound assessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Lung resection surgery | Adult patients scheduled for elective lobectomy surgery under one-lung ventilation in a tertiary referral hospital. Receives: Diagnostic Test: Perioperative lung ultrasound assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung aeration after lung resection surgery assessed by lung ultrasound score
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.
Measured: preoperative vs immediate postoperative period vs 24 hours after surgery
Secondary outcomes (5)
Regional distribution of lung ultrasound findings in the operated and non-operated lung
Description of lung ultrasound findings and lung aeration loss in each lung region at the predefined perioperative time points.
Measured: preoperative vs immediate postoperative period vs 24 hours after surgery
Changes in oxygenation after lung resection surgery
Oxygenation will be assessed using the PaO₂/FiO₂ ratio at the predefined perioperative time points.
Measured: preoperative vs immediate postoperative vs 24 hours after surgery
Changes in plasma inflammatory biomarkers after lung resection 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.
Measured: preoperative vs immediate postoperative vs 24 hours after surgery
Changes in cardiac stress markers after lung resection surgery
NT-proBNP values will be assessed at the predefined perioperative time points and explored in relation to lung ultrasound findings.
Measured: preoperative vs immediate postoperative vs 24 hours after surgery
Changes in diaphragmatic function after lung resection surgery
Diaphragmatic function will be assessed by ultrasound using diaphragmatic thickening fraction at the predefined perioperative time points.
Measured: preoperative vs immediate postoperative vs 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start20 Dec 2020
- Primary completion30 Jan 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ana Broseta Lleó
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario de Valencia
- Responsible party
- Sponsor-investigator, Ana Broseta Lleó, Hospital General Universitario de Valencia
- Investigators
- Ana Broseta Lleó, Consultant, Principal investigator, Hospital General Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677309
- Sponsor's protocol ID
- THORUS
- Acronym
- THORUS
- Status last verified
- Jun 2026
- First submitted
- 24 Nov 2020
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Assessment of Aeration Changes After Lung Resection Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT04677309
- Acronym / sponsor ID
- THORUS / THORUS
- Conditions
- Lung Neoplasm, Lung Cancer, Lung Resection Surgery, Thoracic Surgery, One-lung Ventilation (OLV), Postoperative Pulmonary Complications (PPCs)
- Keywords
- thoracic surgery, lung ultrasound, lung aeration, lung ultrasound score, lung resection, lobectomy, one-lung ventilation, postoperative pulmonary complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ana Broseta LleóUniversity, hospital or other
- Collaborators
- Hospital General Universitario de Valencia
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung resection surgery | – | Diagnostic Test: Perioperative lung ultrasound assessmentAdult patients scheduled for elective lobectomy surgery under one-lung ventilation in a tertiary referral hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective lung resection surgery at a tertiary referral hospital.
Key inclusion criteria (5 listed)
- Age > 18
- ASA I-III
- Non-small cell lung neoplasm
- Elective lobectomy
- Under one-lung ventilation
Key exclusion criteria (15 listed)
- pregnancy
- Diagnosed pulmonary fibrosis
- Scheduled surgery limited to biopsy
- Surgery that includes resection of the thoracic wall or the diaphragm
- Predicted FEV1 < 40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative lung ultrasound assessmentLung 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. | Diagnostic test | Lung resection surgery |
Primary outcome
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.
5 secondary outcomes
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
Changes in oxygenation after lung resection surgery
Time frame: preoperative vs immediate postoperative vs 24 hours after surgery
Changes in plasma inflammatory biomarkers after lung resection surgery
Time frame: preoperative vs immediate postoperative vs 24 hours after surgery
Changes in cardiac stress markers after lung resection surgery
Time frame: preoperative vs immediate postoperative vs 24 hours after surgery
Changes in diaphragmatic function after lung resection surgery
Time frame: preoperative vs immediate postoperative vs 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Broseta Lleó, Consultant principal investigator
Hospital General Universitario de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasm and Lung Cancer, run by Ana Broseta Lleó at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.