Right Side of Heart Function After Lung Surgery
The Pulmonary Vascular / Right Ventricular Response to Lung Resection
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Lung cancer is the second most common cancer in the UK. In suitable cases the best chance of cure is surgical resection. Studies suggest that lung resection is associated with right ventricular (RV) dysfunction, predisposing to complications and post-operative dyspnoea. Studies of RV function following lung resection have been hampered by the limitations of the techniques used. In addition the mechanism of RV dysfunction has remained elusive.
In this prospective observational study the RV response to lung resection will be characterised by sequential assessment of right ventricular ejection fraction (RVEF) measured using cardiovascular magnetic resonance (CMR). CMR is non-invasive, involves no ionising radiation and due to its high spatial resolution is the gold standard for assessing RV volumes. Comprehensive CMR and echocardiographic assessment of the pulmonary vascular - RV axis will allow us to interpret peri-operative changes in RVEF in the context of RV contractility and loading indices. In addition, contemporaneous blood samples will be taken for measurement of biomarkers of myocardial and endothelial dysfunction and systemic inflammation.
With increased understanding of the mechanisms involved, it may be possible to prevent RV dysfunction; reducing complication rates, hospital stay and costs and ameliorating long term dyspnoea.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Clydebank, Reino Unido
- Golden Jubilee National Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Provision of informed consent
- Age >16 years
- Planned elective lung resection by lobectomy
Exclusion Criteria:
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
Contraindications to magnetic resonance imaging:
i. Cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant ii. Aneurysm clips iii. Metal injuries to the eye iv. Loose metal in an part of the body
- Wedge / segmental / sub-lobar lung resection
- Pneumonectomy
- Isolated right middle lobectomy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Study population - lung resection
Patients with suspected lung cancer undergoing lung resection by anatomic lobectomy
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Right ventricular ejection fraction
Periodo de tiempo: 3 days
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The primary objective of this study is determine whether RVEF falls post-operatively in patients undergoing lung resection.
The primary outcome is RVEF at 3 days post-lung resection compared to pre-operative values determined by CMR.
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3 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Association between RVEF and contractility / loading indices
Periodo de tiempo: 3 days
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Changes in RVEF must be interpreted in the context of changes in RV contractility and loading parameters. Changes in pre-load, contractility, afterload, ventriculo-arterial coupling, diastolic function and the position of the mediastinum could all potentially influence RVEF.The following indices will be subject to assessment as secondary endpoints: Preload - Right ventricular end-diastolic volume (RVEDV) Contractility - Peak systolic strain and strain rate Afterload - Pulmonary artery (PA) distensibility, PA peak velocitly, PA antegrade flow, Estimated PA systolic pressure,Pulmonary artery acceleration time Ventriculo-arterial coupling: Ea/Emax(CMR) Diastolic function: E/A velocity ratio. |
3 days
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RVEF vs LVEF
Periodo de tiempo: 3 days
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Changes in right-sided cardiac function must be interpreted in the context of left-sided function.
ΔRVEF will be compared to changes in Left Ventricular Ejection Fraction (LVEF) over the same period.
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3 days
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Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ΔRVEF
Periodo de tiempo: 3 days
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Association between biomarkers of myocardial and endothelial dysfunction, systemic inflammation, oxidative and nitrosative stress and ΔRVEF. Myocardial dysfunction: Brain natriuretic peptide and high sensitivity Troponin-T. Systemic inflammation: C-reactive protein and Pentraxin 3. Oxidative / Nitrosative stress: Malondialdehyde, nitrate and nitrite (determined in plasma and endobronchial aspirate and the end of surgery). Endothelial dysfunction: Angiopoietin (Ang) 1 & 2, Von Willebrand factor (VWf), E-selectin (ESEL) and soluble intracellular adhesion molecule (sICAM)). |
3 days
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Association between RVEF and functional status
Periodo de tiempo: 3 months and 1 year
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Association between RVEFpreop, RVEFpostop, and RVEF3months and functional status by self report and 6-minute walk test (6MWT).
Functional status will be assessed subjectively by written questionnaire.
Scoring will be based on the New York Heart Association (NYHA) classification, WHO performance status classification and health related quality of life scoring by EQ-5D questionnaire.
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3 months and 1 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ben Shelley, MB ChB, University of Glasgow
Publicaciones y enlaces útiles
Publicaciones Generales
- Glass A, McCall P, Arthur A, Mangion K, Shelley B. Pulmonary artery wave reflection and right ventricular function after lung resection. Br J Anaesth. 2023 Jan;130(1):e128-e136. doi: 10.1016/j.bja.2022.07.052. Epub 2022 Sep 15.
- Young DJ, McCall PJ, Kirk A, Macfie A, Kinsella J, Shelley BG. B-type natriuretic peptide predicts deterioration in functional capacity following lung resection. Interact Cardiovasc Thorac Surg. 2019 Jun 1;28(6):945-952. doi: 10.1093/icvts/ivz016.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1-shelly
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