Clinical trial · Observational

Right Ventricular Afterload Indices in Lung Surgery

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

NCT07812207CI-TRIAL-00126202RAILSnot yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Lung Cancer (Suspected or Confirmed)	Malignant Lung Neoplasm	CURATED_EXACT	0.85
One Lung Ventillation (OLV)	—	UNRESOLVED	—
Thoracoscopic Lobectomy	—	UNRESOLVED	—

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Contrast cardiac magnetic resonance imaging	Diagnostic Test	—	UNRESOLVED
Perioperative plasma sampling	Diagnostic Test	—	UNRESOLVED
Quality of recovery scale	Other	—	UNRESOLVED
Right heart catheterisation	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Proportion of patients for whom meaningful haemodynamic data is obtained at clinically relevant timepoints
timeFrame
24 hours
description
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.

Secondary outcomes (10)

measure
Haemodynamic 1: PVR vs time
timeFrame
24 hours
description
Perioperative PVR (Wood units) vs. time (seconds) area under the curve (AUC)
measure
Haemodynamic 2: RHC-derived vs. CMR-derived pulmonary artery flow

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

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

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 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.

References

Publications (4)

BACKGROUNDMurphy 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.
BACKGROUNDMurphy 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. PMID 39957495
BACKGROUNDShelley 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. PMID 35973839
BACKGROUNDMcCall 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. PMID 30826095