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Lung Cancer (Suspected or Confirmed)RAILSNCT07812207

Right Ventricular Afterload Indices in Lung Surgery

An observational study of Lung Cancer (Suspected or Confirmed) and Thoracoscopic Lobectomy, run by University of Glasgow.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Lung cancer is a leading cause of cancer death in Scotland and the UK. Surgery, typically using a keyhole approach, provides the best chance of cure. Golden Jubilee National Hospital performs over 600 operations each year, making this the busiest lung surgery department in the country. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Contrast cardiac magnetic resonance imaging, Right heart catheterisation and Perioperative plasma sampling
How many people
15 participants
Where
No sites listed yet
Study dates
Oct 2026to Oct 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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: The study population will be comprised of elective (planned) adult patients listed for minimally invasive (robotic- or video-assisted thoracoscopic surgery: RATS, VATS) lobectomy for lung cancer under general anaesthesia with one-lung ventilation at GJNH, a large national tertiary cardiothoracic centre located in Clydebank, Glasgow, UK.

Who may be able to join

  • Age ≥18
  • Presumed or confirmed non-small cell lung cancer
  • Planned (elective) minimally invasive (VATS/RATS) lobectomy using OLV
  • Able to provide informed consent

Who cannot join

  • Pulmonary / RV physiological: Severe right sided valvular (tricuspid, pulmonary) disease, Preoperative atrial fibrillation / flutter / non-controlled tachydysrhythmia, Severe RA/RV dilatation, Severe PH (mPAP >55mmHg).
  • Awake RHC contraindicated: Severe coagulopathy (PTr >1.5, PTTr >1.5), Thrombocytopenia (<50x109/L), Abnormal vasculature, Unable to lie supine and head down, Endocarditis or intra-cardiac tumour or thrombus, Right-sided valve prosthesis or other implanted cardiac device (e.g. pacing wire), Skin/soft tissue infection overlying insertion point.
  • CMR contraindicated: Severe claustrophobia/unable to lie supine, Class III obesity (BMI >40), Presence of non-MRI compatible foreign body or implanted device.
  • Gadolinium contrast contraindicated: CMR contraindicated (as above) and/or: Intravenous (IV) contrast (Gadolinium) allergy, Acute or chronic renal failure (eGFR <59ml/min).
  • Surgical / medical: Planned sub-lobar resection / wedge resection / isolated middle lobectomy / segmentectomy / pneumonectomy, Planned secondary procedure (e.g. mediastinal/cardiac), Pregnancy.
  • Research: Ongoing participation in other investigational research which would undermine the scientific basis of this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Characterising Pressure-derived Right Ventricular Afterload Indices During Lung Resection Surgery - a Feasibility Study

Lung cancer is a leading cause of cancer death in Scotland and the UK. Surgery, typically using a keyhole approach, provides the best chance of cure. Golden Jubilee National Hospital performs over 600 operations each year, making this the busiest lung surgery department in the country. Unfortunately, some patients suffer disabling breathlessness and a limited ability to perform even very gentle exercise after surgery, even if they had no breathing problems before surgery. Understanding the causes and preventing this breathlessness is the focus of this research.

Despite advances in techniques, lung cancer surgery can result in long-term weakening of the muscular chamber of the right (-hand side of the) heart which pumps blood to the lungs. During surgery, the pressure against which this pump works increases, making it more difficult to push blood into the lungs.

Read more

Even after surgery, when the pressure returns to normal, the right heart can remain weak. This weakening can contribute to breathlessness and exercise limitation. Preventing or reducing this right heart weakening may improve quality of life after surgery.

The investigators are interested in understanding why this weakening occurs after lung surgery and then to develop treatments to prevent it. The answer may lie in reversing the high resistance against which the heart pumps during surgery. Ultimately, the aim is to improve patients' recovery from surgery and improve both breathing and the ability to exercise. This problem may be treatable with existing drugs which are proven to be safe, easy to deliver and are already available. These drugs can be given around the time of surgery.

This study will not involve administering new treatments, though future clinical trial(s) are anticipated. Participants' care will be the same as is usually provided. Participants taking part will undergo more tests and monitoring than usual to help understand the changes taking place during and after surgery.

Before a drug trial to test this idea, there are some key things to clarify . This study plans to recruit 15 participants having keyhole lung cancer surgery. The following will be performed:

  • Blood Tests: blood samples before and after surgery to check for heart injury.
  • Heart monitoring: temporarily insert a thin tube called a right heart catheter into a large blood vessel in the participants' neck the morning of surgery. This will allow continuous measurement of the pressure in the right heart and lung blood vessels. This will help design and deliver treatments, and how best to measure the effects. This heart catheter will be removed the day after surgery.
  • Heart scans: perform magnetic resonance imaging (MRI) scans before and after surgery to measure blood flow and examine the impact of surgery on the heart.
Read the detailed description

The investigators hypothesise that a transient, acute rise in right ventricular (RV) afterload occurring during lung resection surgery triggers a sterile inflammatory RV injury resulting in persistent RV dysfunction - even in the absence of sustained postoperative pulmonary vascular resistance - which contributes to disabling postoperative dyspnoea and exercise limitation.

Therapeutic pulmonary vasodilation is a mainstay of treatment to reduce RV afterload and improve V/Q matching in complex conditions such as pulmonary hypertension, thoracic organ transplant, respiratory distress syndromes and congenital cardiac disease, with well-established safety and feasibility profiles. Anti-inflammatory and cytoprotective properties have also been demonstrated. The inhaled route provides systemic and renovascular stability, ease of administration, selective targeting of the pulmonary vasculature, with high bioavailability and a short half-life. Unlike traditional approaches focussing on PH management, the application of IPVs for postoperative RV dysfunction may simultaneously address both contractility and afterload reduction.

Perioperative inhaled pulmonary vasodilator (IPV) therapy may prove to protect the RV from the relatively homogenous insult occurring in controlled clinical conditions as described above. Prior to clinical trials of IPVs, it is necessary to first demonstrate the feasibility of continuous RV / pulmonary vascular haemodynamic perioperative monitoring in lung resection, understand the time course of the perioperative afterload insult and characterise pulmonary vasoreactivity. This study seeks to characterise intraoperative haemodynamics, demonstrating feasibility and inform power calculation for a future early phase IPV trial in lung resection patients.

Aims

Perform a pragmatic single-centre, prospective study of adults undergoing elective lung resection by VATS and RATS to:

  • Assess the feasibility and quality of continuous pressure-derived right ventricular afterload measurement using right heart catheterisation in contemporary elective thoracic surgical patient pathway.
  • Characterise perioperative RV and PA haemodynamics (PVR/time area under curve relationship) throughout the perioperative lung resection pathway.
  • Quantify perioperative pulmonary vasoreactivity.

Methods

  • RHC and continuous cardiac output (CCO) monitoring with novel "RVCO" (right ventricular cardiac output) algorithm to permit continuous perioperative RV/pulmonary haemodynamic measures.
  • Contrast CMR to quantify cardiopulmonary blood flow, as the gold standard measure against which other measures (RHC) are compared.
  • Interval cardiac biomarker (HsTn \& BNP) measurement to provide standard for measurement of perioperative RV injury.
  • Characterise perioperative pulmonary vasoreactivity using oxygen and iNO.
  • Conduct validated patient-reported quality of recovery questionnaires.

Primary objective

  • Assess the feasibility of collecting perioperative RHC-derived CCO RV/pulmonary haemodynamic data in 15 adult patients undergoing elective lung resection.

Secondary objectives

  • Obtain perioperative (esp. intraoperative) PVR vs time area under the curve (AUC).
  • Characterise scale, chronology and predictability of intraoperative pulmonary vasoreactivity.
  • Quantify the cardiac bio-inflammatory response to lung resection.
  • Clinical and patient-reported outcome measures.
  • Assess the precision of RHC-measured, RVP waveform-derived PA flow waveform against CMR (gold standard for flow volumes).
Being tested
Contrast cardiac magnetic resonance imaging, Right heart catheterisation, Perioperative plasma sampling, Quality of recovery scale
Keywords
hemodynamics, lung resection, right ventricle, afterload
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Contrast cardiac magnetic resonance imagingDiagnostic test

    2 scans per participant: 1 pre-operatively and 1 post-operatively.

  • Right heart catheterisationDiagnostic test

    Via internal jugular vein using ultrasound and x-ray guidance for diagnostic right heart haemodynamic monitoring

  • Perioperative plasma samplingDiagnostic test

    High-sensitivity troponin \& B-type natriuretic peptide

  • Quality of recovery scaleOther

    Completed by each participants on two occasions: preoperatively and postoperatively. Using validated QoR-15 scale.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients for whom meaningful haemodynamic data is obtained at clinically relevant timepoints

    Time per patient from initiation of right heart catheter (RHC)-derived continuous cardiac output (CCO) monitoring to planned postoperative RHC removal that high-quality* RV/pulmonary haemodynamic data is obtained: *High quality defined as: ≥80% of patients (≥12/15) in whom ≥80% of planned time point measurements can be obtained for the duration of the planned (24 hour) CCO monitoring window. Proportion of planned time per patient in which RHC provides any CCO monitoring for the duration of the planned (24 hour) CCO monitoring window. Number of patients in whom RHC dislodged and/or premature removal required.

    Measured: 24 hours

Secondary outcomes (10)
  1. Haemodynamic 1: PVR vs time

    Perioperative PVR (Wood units) vs. time (seconds) area under the curve (AUC)

    Measured: 24 hours

  2. Haemodynamic 2: RHC-derived vs. CMR-derived pulmonary artery flow

    RHC-derived PA flow (RVP waveform analysis: L/min) vs CMR-derived PA flow (L/min)

    Measured: 24 hours

  3. Vasoreactivity

    % reduction in PVR on vasoreactivity testing (before vs during vs after OLV).

    Measured: 24 hours

  4. Cardiac biomarker 1: BNP

    Serum B-type natriuretic peptide (BNP) level preoperatively, postoperative days 1 and 2.

    Measured: 48 hours

  5. Cardiac biomarker 2: HsTn

    Serum high-sensitivity troponin (HsTn) level preoperatively, postoperative days 1 and 2.

    Measured: 48 hours

  6. Clinical indicator 1: Length of stay

    Length of postoperative hospital stay (days)

    Measured: 30 days

  7. Clinical indicator 2: Mortality

    Mortality at 30 days.

    Measured: 30 days

  8. Clinical indicator 3: Unplanned hospital readmission (all cause)

    Unplanned hospital readmission (all cause) at 30 days.

    Measured: 30 days

  9. Validated patient-reported outcome: quality of recovery

    Fifteen-item Quality of Recovery-15 (QoR-15) scale, a fifteen-item patient-reported questionnaire, each question scored on 11-point scale from 0-10, where 0 is very poor and 10 is excellent. Minimum score 0, maximum score 150.

    Measured: 48 hours

  10. Postoperative complications at 30 days: highest Clavien-Dindo score

    Postoperative in-hospital complications during index surgical admission within 30 days of surgery.

    The outcome measure is the highest Clavien-Dindo score (only score ≥2 included) [scored 1-5 with 5 representing the greatest degree of severity] informed by the Standardising Endpoints in Perioperative trials consensus definitions. The following complication domains are included:

    1. Cardiovascular
    2. Renal
    3. Pulmonary
    4. Infection
    5. Neurological

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07812207
Sponsor's protocol ID
332268
Other IDs
MR/X502807/1
Acronym
RAILS
Status last verified
Sep 2026
First submitted
24 Aug 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Murphy E, Glass A, McCall P, Shelley B. Myocardial inflammation after major non-cardiac thoracic surgery. British Journal of Anaesthesia, 126, e80-e81. DOI: 10.1016/j.bja.2020.11.012.

  • Murphy E, Glass A, McCall P, Shelley B. Peri-operative kinetics of B-type natriuretic peptide and N-terminal pro B-type natriuretic peptide in patients undergoing lung resection: An observational cohort study. Eur J Anaesthesiol. 2025 May 1;42(5):480-482. doi: 10.1097/EJA.0000000000002137. Epub 2025 Feb 14. No abstract available.

    PubMed 39957495
  • Shelley B, Glass A, Keast T, McErlane J, Hughes C, Lafferty B, Marczin N, McCall P. Perioperative cardiovascular pathophysiology in patients undergoing lung resection surgery: a narrative review. Br J Anaesth. 2023 Jan;130(1):e66-e79. doi: 10.1016/j.bja.2022.06.035. Epub 2022 Aug 13.

    PubMed 35973839
  • McCall PJ, Arthur A, Glass A, Corcoran DS, Kirk A, Macfie A, Payne J, Johnson M, Kinsella J, Shelley BG. The right ventricular response to lung resection. J Thorac Cardiovasc Surg. 2019 Aug;158(2):556-565.e5. doi: 10.1016/j.jtcvs.2019.01.067. Epub 2019 Jan 26.

    PubMed 30826095

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer (Suspected or Confirmed) and Thoracoscopic Lobectomy, run by University of Glasgow.

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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ben Shelley, MBChB, MD (+44(0)1419515000 ext. 4293, benjamin.shelley@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients for whom meaningful haemodynamic data is obtained at clinically relevant timepoints (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07812207, which also lists 4 linked publications.

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 10 Sep 2026.

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