Lung NeoplasmOPEN THORUSNCT04755478
LUS to Assess Lung Injury After Lung Lobectomy
An observational study of Lung Neoplasm and Adult ALL, run by Hospital General Universitario de Valencia at 1 site in Spain.
Trial summary
The purpose of the study is to assess whether lung ultrasound is able to detect lung injury after lung resection surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm, Adult ALL, Lung Injury
- What is being tested?
- Thoracotomy and VATS
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jan 2021to 31 Oct 2021
- 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 assigned to a tertiary referral hospital
Who may be able to join
- Age > 18
- ASA I-III
- Non-small cell lung neoplasm
- Elective lung lobectomy
- Under one-lung ventilation
Who cannot join
- Pregnancy
- Respiratory tract infection the previous month
- Diagnosed pulmonary fibrosis
- Predicted FEV < 40%
- Surgery that includes resection of the thoracic wall or the diaphragm
- Neoplasm metastasis
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario de Valencia
Valencia, 46014
Ana Broseta Lleó, Consultant, 656575897, ana.broseta@gmail.com
About this study
Official title: Ultrasound Assessment of Aeration Changes After Lung Lobectomy: a Pilot Study
The purpose of the study is to assess whether lung ultrasound is able to detect lung injury after lung resection surgery.
Read the detailed description
Postoperative pulmonary complications (PPC) are common after lung resection surgery, with an incidence that ranges between 11-32%. As PPC are associated with worse outcomes, many studies aim to find predictors that identify high risk patients and prompt specific interventions and/or monitoring and hence, improve outcomes. PPC result from lung injury inherent to lung resection surgery. Lung aeration changes seen with lung ultrasound (LUS) could detect lung injury and thus, identify patients at high risk of PPC. The underlying mechanisms of lung injury are different in the dependent and non-dependent lung; oxidative stress in both lungs, lung injury associated with one-lung ventilation in the dependent lung and ischemia/reperfusion or surgical manipulation in the non-dependent lung. LUS evaluates the dependent and non-dependent lung separately and so it can be valuable in understanding the characteristics and intensity of lung injury in each lung specifically.
This is a prospective, single-centre, observational study in which 30 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 15 patients in each group. LUS will be performed in each participant's operated and non-operated 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 anaesthesiologists. 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 investigators 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
- Lung Neoplasm, Adult ALL, Lung Injury, Lung Inflammation, Lung Ischemia/Hypoxia, Postoperative Complications
- Being tested
- Thoracotomy, VATS
- Keywords
- thoracic surgery, lung ultrasound, cytokines blood, lung injury, postoperative complications
- Medical subject headings
- Lung Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lung Injury, Pneumonia, Hypoxia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoracotomyProcedure or surgery
Participants will undergo lobectomy via open thoracotomy at the discretion of the surgical team.
VATSProcedure or surgery
Participants will undergo lobectomy via VATS at the discretion of the surgical team.
| Study group | Role | What they receive |
|---|---|---|
| Lung lobectomy via open thoracotomy | participants scheduled for lung lobectomy via open thoracotomy Receives: Procedure: Thoracotomy | |
| Lung lobectomy via VATS | participants scheduled for lung lobectomy via video-assisted thoracoscopic surgery Receives: Procedure: VATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mLUSS after lung resection.
The modified lung ultrasound score (mLUSS) ranges 0-36; the higher the score, the less aeration (worse).
Measured: preoperative vs immediate postoperative period vs 24 hours after surgery.
Secondary outcomes (6)
LUS feasibility in the dependent and non-dependent lung.
Percetage of patients in which ultrasound examination is feasible. There is no important surgical emphysema and/or the dressings or chest tubes do not preclude the feasibility of the examination.
Measured: Preoperative vs immediate postoperative period vs 24 hours after surgery.
Changes in oxygenation (PAFI) after lung resection.
PAFI is the ratio between paO2 and fraction of inspired oxygen; the lower, the worse.
Measured: Preoperative vs immediate postoperative vs 24 hours after surgery.
Changes in plasma cytokine IL-6 after lung resection.
Measured: Preoperative vs immediate postoperative vs 24 hours after surgery.
Changes in plasma cytokine IL-10 after lung resection.
Measured: Preoperative vs immediate postoperative vs 24 hours after surgery.
Changes in plasma TNFα after lung resection.
Measured: Preoperative vs immediate postoperative vs 24 hours after surgery.
Changes in blood bone natriuretic peptide (BNP) after lung resection.
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 posted16 Feb 2021
- Study start28 Jan 2021
- Primary completion30 Aug 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT04755478
- Sponsor's protocol ID
- OPEN THORUS
- Acronym
- OPEN THORUS
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 16 Feb 2021
- 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 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Aeration Changes After Lung Lobectomy: a Pilot Study
- ClinicalTrials.gov ID
- NCT04755478
- Acronym / sponsor ID
- OPEN THORUS / OPEN THORUS
- Conditions
- Lung Neoplasm, Adult ALL, Lung Injury, Lung Inflammation, Lung Ischemia/Hypoxia, Postoperative Complications
- Keywords
- thoracic surgery, lung ultrasound, cytokines blood, lung injury, postoperative complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital General Universitario de ValenciaUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 16 Feb 2021 (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 the study is to assess whether lung ultrasound is able to detect lung injury after lung resection surgery.
Detailed description
Postoperative pulmonary complications (PPC) are common after lung resection surgery, with an incidence that ranges between 11-32%. As PPC are associated with worse outcomes, many studies aim to find predictors that identify high risk patients and prompt specific interventions and/or monitoring and hence, improve outcomes. PPC result from lung injury inherent to lung resection surgery. Lung aeration changes seen with lung ultrasound (LUS) could detect lung injury and thus, identify patients at high risk of PPC. The underlying mechanisms of lung injury are different in the dependent and non-dependent lung; oxidative stress in both lungs, lung injury associated with one-lung ventilation in the dependent lung and ischemia/reperfusion or surgical manipulation in the non-dependent lung. LUS evaluates the dependent and non-dependent lung separately and so it can be valuable in understanding the characteristics and intensity of lung injury in each lung specifically.
This is a prospective, single-centre, observational study in which 30 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 15 patients in each group. LUS will be performed in each participant's operated and non-operated 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 anaesthesiologists. 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 investigators 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung lobectomy via open thoracotomy | – | Procedure: Thoracotomyparticipants scheduled for lung lobectomy via open thoracotomy |
| Lung lobectomy via VATS | – | Procedure: VATSparticipants scheduled for lung lobectomy via video-assisted thoracoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients assigned to a tertiary referral hospital
Key inclusion criteria (5 listed)
- Age > 18
- ASA I-III
- Non-small cell lung neoplasm
- Elective lung lobectomy
- Under one-lung ventilation
Key exclusion criteria (16 listed)
- Pregnancy
- Respiratory tract infection the previous month
- Diagnosed pulmonary fibrosis
- Predicted FEV < 40%
- Surgery that includes resection of the thoracic wall or the diaphragm
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 |
|---|---|---|
| ThoracotomyParticipants will undergo lobectomy via open thoracotomy at the discretion of the surgical team. | Procedure or surgery | Lung lobectomy via open thoracotomy |
| VATSParticipants will undergo lobectomy via VATS at the discretion of the surgical team. | Procedure or surgery | Lung lobectomy via VATS |
Primary outcome
Change in mLUSS after lung resection.
Time frame: preoperative vs immediate postoperative period vs 24 hours after surgery.
The modified lung ultrasound score (mLUSS) ranges 0-36; the higher the score, the less aeration (worse).
6 secondary outcomes
LUS feasibility in the dependent and non-dependent lung.
Time frame: Preoperative vs immediate postoperative period vs 24 hours after surgery.
Changes in oxygenation (PAFI) after lung resection.
Time frame: Preoperative vs immediate postoperative vs 24 hours after surgery.
Changes in plasma cytokine IL-6 after lung resection.
Time frame: Preoperative vs immediate postoperative vs 24 hours after surgery.
Changes in plasma cytokine IL-10 after lung resection.
Time frame: Preoperative vs immediate postoperative vs 24 hours after surgery.
Changes in plasma TNFα after lung resection.
Time frame: Preoperative vs immediate postoperative vs 24 hours after surgery.
Changes in blood bone natriuretic peptide (BNP) after lung resection.
Time frame: Preoperative vs immediate postoperative vs 24 hours after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- 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 Adult ALL, run by Hospital General Universitario de Valencia 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 16 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Broseta Lleó, Consultant anaesthesiologist (656575897, ana.broseta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mLUSS after lung resection. (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 16 Feb 2021.