ClinicalTrials.gg
Not yet recruitingNCT07812207RAILSUpdated Sep 10, 2026

Right Ventricular Afterload Indices in Lung Surgery

An observational study in Lung Cancer (Suspected or Confirmed), Thoracoscopic Lobectomy and One Lung Ventillation (OLV), sponsored by University of Glasgow. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by University of Glasgow · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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).
02

Conditions studied

  • Lung Cancer (Suspected or Confirmed)
  • Thoracoscopic Lobectomy
  • One Lung Ventillation (OLV)

Browse trials for

Keywords

  • hemodynamics
  • lung resection
  • right ventricle
  • afterload
03

In context

Lung Neoplasms

5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.

This study's planned enrollment of 15 is below the median of 200 across 1,434 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Glasgow is the lead sponsor of 145 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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 : 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 ( >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 ( \<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 research which would undermine the scientific basis of this study.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic testContrast cardiac magnetic resonance imaging

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

  • Diagnostic testRight heart catheterisation

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

  • Diagnostic testPerioperative plasma sampling

    High-sensitivity troponin \& B-type natriuretic peptide

  • OtherQuality of recovery scale

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 24 hours

Secondary outcomes

  1. Haemodynamic 1: PVR vs time

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

    Time frame: 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)

    Time frame: 24 hours

  3. Vasoreactivity

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

    Time frame: 24 hours

  4. Cardiac biomarker 1: BNP

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

    Time frame: 48 hours

  5. Cardiac biomarker 2: HsTn

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

    Time frame: 48 hours

  6. Clinical indicator 1: Length of stay

    Length of postoperative hospital stay (days)

    Time frame: 30 days

  7. Clinical indicator 2: Mortality

    Mortality at 30 days.

    Time frame: 30 days

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

    Unplanned hospital readmission (all cause) at 30 days.

    Time frame: 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.

    Time frame: 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

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07812207
Collaborators
Golden Jubilee National Hospital
Responsible party
Dr Ben Shelley (Honorary Professor, University of Glasgow) — Principal investigator
First posted
Sep 10, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Ben Shelley, MBChB, MD
Contact
benjamin.shelley@glasgow.ac.uk
+44(0)1419515000 ext. 4293
Gareth Lipton, MBChB
Contact
gareth.lipton@glasgow.ac.uk
+44(0)1419515000 ext. 4293

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion