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Carbon dioxide flushing versus saline flushing of thoracic aortic stents (INTERCEPTevar): protocol for a multicentre pilot randomised controlled trial

INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) carries a 3%–6.1% stroke risk, including risk of ‘silent’ cerebral infarction (SCI). Stent-grafts are manufactured in room air and retain air. Instructions for use recommend saline flushing to ‘de-air’ the system prior to insertion, but subst...

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Autores principales: Crockett, Stephen, Hanna, Lydia, Singh, Abhinav, Gunning, Stephen, Nicholas, Richard, Bicknell, Colin, Hamady, Mohamad, Gable, Dennis, Sallam, Morad, Modarai, Bijan, Abisi, Said, Lyons, Oliver, Gibbs, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10151986/
https://www.ncbi.nlm.nih.gov/pubmed/37105705
http://dx.doi.org/10.1136/bmjopen-2022-067605
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author Crockett, Stephen
Hanna, Lydia
Singh, Abhinav
Gunning, Stephen
Nicholas, Richard
Bicknell, Colin
Hamady, Mohamad
Gable, Dennis
Sallam, Morad
Modarai, Bijan
Abisi, Said
Lyons, Oliver
Gibbs, Richard
author_facet Crockett, Stephen
Hanna, Lydia
Singh, Abhinav
Gunning, Stephen
Nicholas, Richard
Bicknell, Colin
Hamady, Mohamad
Gable, Dennis
Sallam, Morad
Modarai, Bijan
Abisi, Said
Lyons, Oliver
Gibbs, Richard
author_sort Crockett, Stephen
collection PubMed
description INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) carries a 3%–6.1% stroke risk, including risk of ‘silent’ cerebral infarction (SCI). Stent-grafts are manufactured in room air and retain air. Instructions for use recommend saline flushing to ‘de-air’ the system prior to insertion, but substantial amounts of air are released when deploying them, potentially leading to downstream neuronal injury and SCI. Carbon dioxide (CO(2)) is more dense and more soluble in blood than air, without risk of bubble formation, so could be used in addition to saline to de-air stents. This pilot trial aims to assess the feasibility of a full-scale randomised controlled trial (RCT) investigating the neuroprotective benefit against SCI with the use of CO(2)-flushed aortic stent-grafts. METHODS AND ANALYSIS: This is a multicentre pilot RCT, which is taking place in vascular centres in the UK, USA and New Zealand. Patients identified for TEVAR will be enrolled after informed written consent. 120 participants will be randomised (1:1) to TEVAR-CO(2) or TEVAR-saline, stratified according to TEVAR landing zone. Participants will undergo preoperative neurocognitive tests and quality of life assessments, which will be repeated at 6 weeks, or first outpatient appointment, and 6 months. Inpatient neurological testing will be performed within 48 hours of return to level 1 care for clinical stroke or delirium. Diffusion-weighted MRI will be undertaken within 72 hours postoperatively (1–7 days) and at 6 months to look for evidence and persistence of SCI. Feasibility will be assessed via measures of recruitment and retention, informing the design of a full-scale trial. ETHICS AND DISSEMINATION: The study coordination centre has obtained approval from the London Fulham Research Ethics Committee (19/LO/0836) and Southern Health and Disability Ethics Committee (NZ) and UK’s Health Regulator Authority (HRA). The study has received ethical approval for recruitment in the UK (Fulham REC, 19/LO/0836), New Zealand (21/STH/192) and the USA (IRB 019-264, Ref 378630). Consent for entering into the study will be taken using standardised consent forms by the local study team, led by a local PI. The results of the trial will be submitted for publication in an open access journal. TRIAL REGISTRATION NUMBER: NCT03886675
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spelling pubmed-101519862023-05-03 Carbon dioxide flushing versus saline flushing of thoracic aortic stents (INTERCEPTevar): protocol for a multicentre pilot randomised controlled trial Crockett, Stephen Hanna, Lydia Singh, Abhinav Gunning, Stephen Nicholas, Richard Bicknell, Colin Hamady, Mohamad Gable, Dennis Sallam, Morad Modarai, Bijan Abisi, Said Lyons, Oliver Gibbs, Richard BMJ Open Surgery INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) carries a 3%–6.1% stroke risk, including risk of ‘silent’ cerebral infarction (SCI). Stent-grafts are manufactured in room air and retain air. Instructions for use recommend saline flushing to ‘de-air’ the system prior to insertion, but substantial amounts of air are released when deploying them, potentially leading to downstream neuronal injury and SCI. Carbon dioxide (CO(2)) is more dense and more soluble in blood than air, without risk of bubble formation, so could be used in addition to saline to de-air stents. This pilot trial aims to assess the feasibility of a full-scale randomised controlled trial (RCT) investigating the neuroprotective benefit against SCI with the use of CO(2)-flushed aortic stent-grafts. METHODS AND ANALYSIS: This is a multicentre pilot RCT, which is taking place in vascular centres in the UK, USA and New Zealand. Patients identified for TEVAR will be enrolled after informed written consent. 120 participants will be randomised (1:1) to TEVAR-CO(2) or TEVAR-saline, stratified according to TEVAR landing zone. Participants will undergo preoperative neurocognitive tests and quality of life assessments, which will be repeated at 6 weeks, or first outpatient appointment, and 6 months. Inpatient neurological testing will be performed within 48 hours of return to level 1 care for clinical stroke or delirium. Diffusion-weighted MRI will be undertaken within 72 hours postoperatively (1–7 days) and at 6 months to look for evidence and persistence of SCI. Feasibility will be assessed via measures of recruitment and retention, informing the design of a full-scale trial. ETHICS AND DISSEMINATION: The study coordination centre has obtained approval from the London Fulham Research Ethics Committee (19/LO/0836) and Southern Health and Disability Ethics Committee (NZ) and UK’s Health Regulator Authority (HRA). The study has received ethical approval for recruitment in the UK (Fulham REC, 19/LO/0836), New Zealand (21/STH/192) and the USA (IRB 019-264, Ref 378630). Consent for entering into the study will be taken using standardised consent forms by the local study team, led by a local PI. The results of the trial will be submitted for publication in an open access journal. TRIAL REGISTRATION NUMBER: NCT03886675 BMJ Publishing Group 2023-04-27 /pmc/articles/PMC10151986/ /pubmed/37105705 http://dx.doi.org/10.1136/bmjopen-2022-067605 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Surgery
Crockett, Stephen
Hanna, Lydia
Singh, Abhinav
Gunning, Stephen
Nicholas, Richard
Bicknell, Colin
Hamady, Mohamad
Gable, Dennis
Sallam, Morad
Modarai, Bijan
Abisi, Said
Lyons, Oliver
Gibbs, Richard
Carbon dioxide flushing versus saline flushing of thoracic aortic stents (INTERCEPTevar): protocol for a multicentre pilot randomised controlled trial
title Carbon dioxide flushing versus saline flushing of thoracic aortic stents (INTERCEPTevar): protocol for a multicentre pilot randomised controlled trial
title_full Carbon dioxide flushing versus saline flushing of thoracic aortic stents (INTERCEPTevar): protocol for a multicentre pilot randomised controlled trial
title_fullStr Carbon dioxide flushing versus saline flushing of thoracic aortic stents (INTERCEPTevar): protocol for a multicentre pilot randomised controlled trial
title_full_unstemmed Carbon dioxide flushing versus saline flushing of thoracic aortic stents (INTERCEPTevar): protocol for a multicentre pilot randomised controlled trial
title_short Carbon dioxide flushing versus saline flushing of thoracic aortic stents (INTERCEPTevar): protocol for a multicentre pilot randomised controlled trial
title_sort carbon dioxide flushing versus saline flushing of thoracic aortic stents (interceptevar): protocol for a multicentre pilot randomised controlled trial
topic Surgery
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10151986/
https://www.ncbi.nlm.nih.gov/pubmed/37105705
http://dx.doi.org/10.1136/bmjopen-2022-067605
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