LUS to Assess Lung Injury After Lung Lobectomy (OPEN THORUS)

February 15, 2021 updated by: Ana Broseta Lleó, Hospital General Universitario de Valencia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ana Broseta Lleó, Consultant anaesthesiologist
  • Phone Number: 656575897
  • Email: ana.broseta@gmail.com

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario De Valencia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients assigned to a tertiary referral hospital

Description

Inclusion Criteria:

  • Age > 18
  • ASA I-III
  • Non-small cell lung neoplasm
  • Elective lung lobectomy
  • Under one-lung ventilation

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Lung lobectomy via open thoracotomy
participants scheduled for lung lobectomy via open thoracotomy
Procedure: Thoracotomy
Participants will undergo lobectomy via open thoracotomy at the discretion of the surgical team.
Lung lobectomy via VATS
participants scheduled for lung lobectomy via video-assisted thoracoscopic surgery
Procedure: VATS
Participants will undergo lobectomy via VATS at the discretion of the surgical team.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
preoperative vs immediate postoperative period vs 24 hours after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
LUS feasibility in the dependent and non-dependent lung.
Time Frame: Preoperative vs immediate postoperative period vs 24 hours after surgery.
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.
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.
PAFI is the ratio between paO2 and fraction of inspired oxygen; the lower, the worse.
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.
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.
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.
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.
Preoperative vs immediate postoperative vs 24 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital General Universitario de Valencia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ana Broseta Lleó, Consultant, Hospital General Universitario De Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPEN THORUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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