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Right Ventricular Afterload Indices in Lung Surgery (RAILS)

3 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Stimato)

15

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of patients for whom meaningful haemodynamic data is obtained at clinically relevant timepoints
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Haemodynamic 1: PVR vs time
Lasso di tempo: 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
Lasso di tempo: 24 hours
RHC-derived PA flow (RVP waveform analysis: L/min) vs CMR-derived PA flow (L/min)
24 hours
Vasoreactivity
Lasso di tempo: 24 hours
% reduction in PVR on vasoreactivity testing (before vs during vs after OLV).
24 hours
Cardiac biomarker 1: BNP
Lasso di tempo: 48 hours
Serum B-type natriuretic peptide (BNP) level preoperatively, postoperative days 1 and 2.
48 hours
Cardiac biomarker 2: HsTn
Lasso di tempo: 48 hours
Serum high-sensitivity troponin (HsTn) level preoperatively, postoperative days 1 and 2.
48 hours
Clinical indicator 1: Length of stay
Lasso di tempo: 30 days
Length of postoperative hospital stay (days)
30 days
Clinical indicator 2: Mortality
Lasso di tempo: 30 days
Mortality at 30 days.
30 days
Clinical indicator 3: Unplanned hospital readmission (all cause)
Lasso di tempo: 30 days
Unplanned hospital readmission (all cause) at 30 days.
30 days
Validated patient-reported outcome: quality of recovery
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 ottobre 2027

Completamento dello studio (Stimato)

1 ottobre 2027

Date di iscrizione allo studio

Primo inviato

24 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 settembre 2026

Primo Inserito (Effettivo)

10 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 332268
  • MR/X502807/1 (Altro numero di sovvenzione/finanziamento: UK Research & Innovation (UKRI) Medical Research Council (MRC) Impact Acceleration Account (IAA))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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