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Carbon dioxide flooding to reduce postoperative neurological injury following surgery for acute type A aortic dissection : a prospective, randomised, blinded, controlled clinical trial, CARTA study protocol - objectives and design

Ede, Jacob LU orcid ; Teurneau-Hermansson, Karl LU orcid ; Moseby-Knappe, Marion LU ; Ramgren, Birgitta LU ; Bjursten, Henrik LU ; Ederoth, Per LU ; Larsson, Mårten LU ; Mattsson-Carlgren, Niklas LU orcid ; Sjögren, Johan LU and Wierup, Per LU , et al. (2023) In BMJ Open 13(5). p.1-8
Abstract

INTRODUCTION: Neurological complications after surgery for acute type A aortic dissection (ATAAD) increase patient morbidity and mortality. Carbon dioxide flooding is commonly used in open-heart surgery to reduce the risk of air embolism and neurological impairment, but it has not been evaluated in the setting of ATAAD surgery. This report describes the objectives and design of the CARTA trial, investigating whether carbon dioxide flooding reduces neurological injury following surgery for ATAAD. METHODS AND ANALYSIS: The CARTA trial is a single-centre, prospective, randomised, blinded, controlled clinical trial of ATAAD surgery with carbon dioxide flooding of the surgical field. Eighty consecutive patients undergoing repair of ATAAD,... (More)

INTRODUCTION: Neurological complications after surgery for acute type A aortic dissection (ATAAD) increase patient morbidity and mortality. Carbon dioxide flooding is commonly used in open-heart surgery to reduce the risk of air embolism and neurological impairment, but it has not been evaluated in the setting of ATAAD surgery. This report describes the objectives and design of the CARTA trial, investigating whether carbon dioxide flooding reduces neurological injury following surgery for ATAAD. METHODS AND ANALYSIS: The CARTA trial is a single-centre, prospective, randomised, blinded, controlled clinical trial of ATAAD surgery with carbon dioxide flooding of the surgical field. Eighty consecutive patients undergoing repair of ATAAD, and who do not have previous neurological injuries or ongoing neurological symptoms, will be randomised (1:1) to either receive carbon dioxide flooding of the surgical field or not. Routine repair will be performed regardless of the intervention. The primary endpoints are size and number of ischaemic lesions on brain MRI performed after surgery. Secondary endpoints are clinical neurological deficit according to the National Institutes of Health Stroke Scale, level of consciousness using the Glasgow Coma Scale motor score, brain injury markers in blood after surgery, neurological function according to the modified Rankin Scale and postoperative recovery 3 months after surgery. ETHICS AND DISSEMINATION: Ethical approval has been granted by Swedish Ethical Review Agency for this study. Results will be disseminated through peer-reviewed media. TRIAL REGISTRATION NUMBER: NCT04962646.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Cardiac surgery, Cardiothoracic surgery, Stroke
in
BMJ Open
volume
13
issue
5
article number
e063837
pages
1 - 8
publisher
BMJ Publishing Group
external identifiers
  • pmid:37230515
  • scopus:85160456276
ISSN
2044-6055
DOI
10.1136/bmjopen-2022-063837
language
English
LU publication?
yes
additional info
Publisher Copyright: © 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.
id
df32d397-424f-49f3-a5f6-14688eb202ce
date added to LUP
2023-06-12 21:42:04
date last changed
2024-04-19 22:48:52
@article{df32d397-424f-49f3-a5f6-14688eb202ce,
  abstract     = {{<p>INTRODUCTION: Neurological complications after surgery for acute type A aortic dissection (ATAAD) increase patient morbidity and mortality. Carbon dioxide flooding is commonly used in open-heart surgery to reduce the risk of air embolism and neurological impairment, but it has not been evaluated in the setting of ATAAD surgery. This report describes the objectives and design of the CARTA trial, investigating whether carbon dioxide flooding reduces neurological injury following surgery for ATAAD. METHODS AND ANALYSIS: The CARTA trial is a single-centre, prospective, randomised, blinded, controlled clinical trial of ATAAD surgery with carbon dioxide flooding of the surgical field. Eighty consecutive patients undergoing repair of ATAAD, and who do not have previous neurological injuries or ongoing neurological symptoms, will be randomised (1:1) to either receive carbon dioxide flooding of the surgical field or not. Routine repair will be performed regardless of the intervention. The primary endpoints are size and number of ischaemic lesions on brain MRI performed after surgery. Secondary endpoints are clinical neurological deficit according to the National Institutes of Health Stroke Scale, level of consciousness using the Glasgow Coma Scale motor score, brain injury markers in blood after surgery, neurological function according to the modified Rankin Scale and postoperative recovery 3 months after surgery. ETHICS AND DISSEMINATION: Ethical approval has been granted by Swedish Ethical Review Agency for this study. Results will be disseminated through peer-reviewed media. TRIAL REGISTRATION NUMBER: NCT04962646.</p>}},
  author       = {{Ede, Jacob and Teurneau-Hermansson, Karl and Moseby-Knappe, Marion and Ramgren, Birgitta and Bjursten, Henrik and Ederoth, Per and Larsson, Mårten and Mattsson-Carlgren, Niklas and Sjögren, Johan and Wierup, Per and Nozohoor, Shahab and Zindovic, Igor}},
  issn         = {{2044-6055}},
  keywords     = {{Cardiac surgery; Cardiothoracic surgery; Stroke}},
  language     = {{eng}},
  month        = {{05}},
  number       = {{5}},
  pages        = {{1--8}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{Carbon dioxide flooding to reduce postoperative neurological injury following surgery for acute type A aortic dissection : a prospective, randomised, blinded, controlled clinical trial, CARTA study protocol - objectives and design}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2022-063837}},
  doi          = {{10.1136/bmjopen-2022-063837}},
  volume       = {{13}},
  year         = {{2023}},
}