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Right Ventricular Afterload Indices in Lung Surgery (RAILS)

3 de setembro de 2026 atualizado por: Dr Ben Shelley, University of Glasgow

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.

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.

Visão geral do estudo

Descrição detalhada

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).

Tipo de estudo

Observacional

Inscrição (Estimado)

15

Contactos e Locais

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Contato de estudo

Estude backup de contato

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of patients for whom meaningful haemodynamic data is obtained at clinically relevant timepoints
Prazo: 24 hours
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.
24 hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Haemodynamic 1: PVR vs time
Prazo: 24 hours
Perioperative PVR (Wood units) vs. time (seconds) area under the curve (AUC)
24 hours
Haemodynamic 2: RHC-derived vs. CMR-derived pulmonary artery flow
Prazo: 24 hours
RHC-derived PA flow (RVP waveform analysis: L/min) vs CMR-derived PA flow (L/min)
24 hours
Vasoreactivity
Prazo: 24 hours
% reduction in PVR on vasoreactivity testing (before vs during vs after OLV).
24 hours
Cardiac biomarker 1: BNP
Prazo: 48 hours
Serum B-type natriuretic peptide (BNP) level preoperatively, postoperative days 1 and 2.
48 hours
Cardiac biomarker 2: HsTn
Prazo: 48 hours
Serum high-sensitivity troponin (HsTn) level preoperatively, postoperative days 1 and 2.
48 hours
Clinical indicator 1: Length of stay
Prazo: 30 days
Length of postoperative hospital stay (days)
30 days
Clinical indicator 2: Mortality
Prazo: 30 days
Mortality at 30 days.
30 days
Clinical indicator 3: Unplanned hospital readmission (all cause)
Prazo: 30 days
Unplanned hospital readmission (all cause) at 30 days.
30 days
Validated patient-reported outcome: quality of recovery
Prazo: 48 hours
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.
48 hours
Postoperative complications at 30 days: highest Clavien-Dindo score
Prazo: 30 days

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
30 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de outubro de 2027

Conclusão do estudo (Estimado)

1 de outubro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

24 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de setembro de 2026

Primeira postagem (Real)

10 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 332268
  • MR/X502807/1 (Número de outro subsídio/financiamento: UK Research & Innovation (UKRI) Medical Research Council (MRC) Impact Acceleration Account (IAA))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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