Right Ventricular Afterload Indices in Lung Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Glasgow

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18

Presumed or confirmed non-small cell lung cancer

Planned (elective) minimally invasive (VATS/RATS) lobectomy using OLV

Able to provide informed consent

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Contrast cardiac magnetic resonance imaging

    Diagnostic test

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

  • Right heart catheterisation

    Diagnostic test

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

  • Perioperative plasma sampling

    Diagnostic test

    High-sensitivity troponin \& B-type natriuretic peptide

  • Quality of recovery scale

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Glasgow

Lead sponsor

Golden Jubilee National Hospital

Collaborator

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