Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3)

Keith Couper; Chen Ji; Ranjit Lall; Charles D Deakin; Rachael Fothergill; John Long; James Mason; Felix Michelet; Jerry P Nolan; Henry Nwankwo; Tom Quinn; Anne-Marie Slowther; Michael A Smyth; Alison Walker; Loraine Chowdhury; Chloe Norman; Laurille Sprauve; Kath Starr; Sara Wood; Steve Bell; Gemma Bradley; Martina Brown; Shona Brown; Karl Charlton; Alison Coppola; Charlotte Evans; Christine Evans; Theresa Foster; Michelle Jackson; Justin Kearney; Nigel Lang; Adam Mellett-Smith; Ria Osborne; Helen Pocock; Nigel Rees; Robert Spaight; Belinda Tibbetts; Gregory A Whitley; Jason Wiles; Julia Williams; Adam Wright; Gavin D Perkins

doi:10.1016/j.resplu.2023.100544

Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3)

Keith Couper, Chen Ji, Ranjit Lall, Charles D Deakin, Rachael Fothergill, John Long, James Mason, Felix Michelet, Jerry P Nolan, Henry Nwankwo, Tom Quinn, Anne-Marie Slowther, Michael A Smyth, Alison Walker, Loraine Chowdhury, Chloe Norman, Laurille Sprauve, Kath Starr, Sara Wood, Steve BellGemma Bradley, Martina Brown, Shona Brown, Karl Charlton, Alison Coppola, Charlotte Evans, Christine Evans, Theresa Foster, Michelle Jackson, Justin Kearney, Nigel Lang, Adam Mellett-Smith, Ria Osborne, Helen Pocock, Nigel Rees, Robert Spaight, Belinda Tibbetts, Gregory A Whitley, Jason Wiles, Julia Williams, Adam Wright, Gavin D Perkins^*

^*Corresponding author for this work

School of Physiology, Pharmacology & Neuroscience

Research output: Contribution to journal › Article (Academic Journal) › peer-review

7 Citations (Scopus)

Abstract

AIMS: The PARAMEDIC-3 trial evaluates the clinical and cost-effectiveness of an intraosseous first strategy, compared with an intravenous first strategy, for drug administration in adults who have sustained an out-of-hospital cardiac arrest.

METHODS: PARAMEDIC-3 is a pragmatic, allocation concealed, open-label, multi-centre, superiority randomised controlled trial. It will recruit 15,000 patients across English and Welsh ambulance services. Adults who have sustained an out-of-hospital cardiac arrest are individually randomised to an intraosseous access first strategy or intravenous access first strategy in a 1:1 ratio through an opaque, sealed envelope system. The randomised allocation determines the route used for the first two attempts at vascular access. Participants are initially enrolled under a deferred consent model.

The primary clinical-effectiveness outcome is survival at 30-days. Secondary outcomes include return of spontaneous circulation, neurological functional outcome, and health-related quality of life. Participants are followed-up to six-months following cardiac arrest. The primary health economic outcome is incremental cost per quality-adjusted life year gained.

CONCLUSION: The PARAMEDIC-3 trial will provide key information on the clinical and cost-effectiveness of drug route in out-of-hospital cardiac arrest.

Trial registration: ISRCTN14223494, registered 16/08/2021, prospectively registered.

Original language	English
Article number	100544
Number of pages	7
Journal	Resuscitation Plus
Volume	17
Early online date	30 Dec 2023
DOIs	https://doi.org/10.1016/j.resplu.2023.100544
Publication status	Published - 1 Mar 2024

Bibliographical note

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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Couper, K., Ji, C., Lall, R., Deakin, C. D., Fothergill, R., Long, J., Mason, J., Michelet, F., Nolan, J. P., Nwankwo, H., Quinn, T., Slowther, A.-M., Smyth, M. A., Walker, A., Chowdhury, L., Norman, C., Sprauve, L., Starr, K., Wood, S., ... Perkins, G. D. (2024). Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3). Resuscitation Plus, 17, Article 100544. https://doi.org/10.1016/j.resplu.2023.100544

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title = "Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3)",

abstract = "AIMS: The PARAMEDIC-3 trial evaluates the clinical and cost-effectiveness of an intraosseous first strategy, compared with an intravenous first strategy, for drug administration in adults who have sustained an out-of-hospital cardiac arrest. METHODS: PARAMEDIC-3 is a pragmatic, allocation concealed, open-label, multi-centre, superiority randomised controlled trial. It will recruit 15,000 patients across English and Welsh ambulance services. Adults who have sustained an out-of-hospital cardiac arrest are individually randomised to an intraosseous access first strategy or intravenous access first strategy in a 1:1 ratio through an opaque, sealed envelope system. The randomised allocation determines the route used for the first two attempts at vascular access. Participants are initially enrolled under a deferred consent model. The primary clinical-effectiveness outcome is survival at 30-days. Secondary outcomes include return of spontaneous circulation, neurological functional outcome, and health-related quality of life. Participants are followed-up to six-months following cardiac arrest. The primary health economic outcome is incremental cost per quality-adjusted life year gained. CONCLUSION: The PARAMEDIC-3 trial will provide key information on the clinical and cost-effectiveness of drug route in out-of-hospital cardiac arrest. Trial registration: ISRCTN14223494, registered 16/08/2021, prospectively registered.",

author = "Keith Couper and Chen Ji and Ranjit Lall and Deakin, \{Charles D\} and Rachael Fothergill and John Long and James Mason and Felix Michelet and Nolan, \{Jerry P\} and Henry Nwankwo and Tom Quinn and Anne-Marie Slowther and Smyth, \{Michael A\} and Alison Walker and Loraine Chowdhury and Chloe Norman and Laurille Sprauve and Kath Starr and Sara Wood and Steve Bell and Gemma Bradley and Martina Brown and Shona Brown and Karl Charlton and Alison Coppola and Charlotte Evans and Christine Evans and Theresa Foster and Michelle Jackson and Justin Kearney and Nigel Lang and Adam Mellett-Smith and Ria Osborne and Helen Pocock and Nigel Rees and Robert Spaight and Belinda Tibbetts and Whitley, \{Gregory A\} and Jason Wiles and Julia Williams and Adam Wright and Perkins, \{Gavin D\}",

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Couper, K, Ji, C, Lall, R, Deakin, CD, Fothergill, R, Long, J, Mason, J, Michelet, F, Nolan, JP, Nwankwo, H, Quinn, T, Slowther, A-M, Smyth, MA, Walker, A, Chowdhury, L, Norman, C, Sprauve, L, Starr, K, Wood, S, Bell, S, Bradley, G, Brown, M, Brown, S, Charlton, K, Coppola, A, Evans, C, Evans, C, Foster, T, Jackson, M, Kearney, J, Lang, N, Mellett-Smith, A, Osborne, R, Pocock, H, Rees, N, Spaight, R, Tibbetts, B, Whitley, GA, Wiles, J, Williams, J, Wright, A & Perkins, GD 2024, 'Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3)', Resuscitation Plus, vol. 17, 100544. https://doi.org/10.1016/j.resplu.2023.100544

TY - JOUR

T1 - Route of drug administration in out-of-hospital cardiac arrest

T2 - A protocol for a randomised controlled trial (PARAMEDIC-3)

AU - Couper, Keith

AU - Ji, Chen

AU - Lall, Ranjit

AU - Deakin, Charles D

AU - Fothergill, Rachael

AU - Long, John

AU - Mason, James

AU - Michelet, Felix

AU - Nolan, Jerry P

AU - Nwankwo, Henry

AU - Quinn, Tom

AU - Slowther, Anne-Marie

AU - Smyth, Michael A

AU - Walker, Alison

AU - Chowdhury, Loraine

AU - Norman, Chloe

AU - Sprauve, Laurille

AU - Starr, Kath

AU - Wood, Sara

AU - Bell, Steve

AU - Bradley, Gemma

AU - Brown, Martina

AU - Brown, Shona

AU - Charlton, Karl

AU - Coppola, Alison

AU - Evans, Charlotte

AU - Evans, Christine

AU - Foster, Theresa

AU - Jackson, Michelle

AU - Kearney, Justin

AU - Lang, Nigel

AU - Mellett-Smith, Adam

AU - Osborne, Ria

AU - Pocock, Helen

AU - Rees, Nigel

AU - Spaight, Robert

AU - Tibbetts, Belinda

AU - Whitley, Gregory A

AU - Wiles, Jason

AU - Williams, Julia

AU - Wright, Adam

AU - Perkins, Gavin D

PY - 2024/3/1

Y1 - 2024/3/1

N2 - AIMS: The PARAMEDIC-3 trial evaluates the clinical and cost-effectiveness of an intraosseous first strategy, compared with an intravenous first strategy, for drug administration in adults who have sustained an out-of-hospital cardiac arrest. METHODS: PARAMEDIC-3 is a pragmatic, allocation concealed, open-label, multi-centre, superiority randomised controlled trial. It will recruit 15,000 patients across English and Welsh ambulance services. Adults who have sustained an out-of-hospital cardiac arrest are individually randomised to an intraosseous access first strategy or intravenous access first strategy in a 1:1 ratio through an opaque, sealed envelope system. The randomised allocation determines the route used for the first two attempts at vascular access. Participants are initially enrolled under a deferred consent model. The primary clinical-effectiveness outcome is survival at 30-days. Secondary outcomes include return of spontaneous circulation, neurological functional outcome, and health-related quality of life. Participants are followed-up to six-months following cardiac arrest. The primary health economic outcome is incremental cost per quality-adjusted life year gained. CONCLUSION: The PARAMEDIC-3 trial will provide key information on the clinical and cost-effectiveness of drug route in out-of-hospital cardiac arrest. Trial registration: ISRCTN14223494, registered 16/08/2021, prospectively registered.

AB - AIMS: The PARAMEDIC-3 trial evaluates the clinical and cost-effectiveness of an intraosseous first strategy, compared with an intravenous first strategy, for drug administration in adults who have sustained an out-of-hospital cardiac arrest. METHODS: PARAMEDIC-3 is a pragmatic, allocation concealed, open-label, multi-centre, superiority randomised controlled trial. It will recruit 15,000 patients across English and Welsh ambulance services. Adults who have sustained an out-of-hospital cardiac arrest are individually randomised to an intraosseous access first strategy or intravenous access first strategy in a 1:1 ratio through an opaque, sealed envelope system. The randomised allocation determines the route used for the first two attempts at vascular access. Participants are initially enrolled under a deferred consent model. The primary clinical-effectiveness outcome is survival at 30-days. Secondary outcomes include return of spontaneous circulation, neurological functional outcome, and health-related quality of life. Participants are followed-up to six-months following cardiac arrest. The primary health economic outcome is incremental cost per quality-adjusted life year gained. CONCLUSION: The PARAMEDIC-3 trial will provide key information on the clinical and cost-effectiveness of drug route in out-of-hospital cardiac arrest. Trial registration: ISRCTN14223494, registered 16/08/2021, prospectively registered.

U2 - 10.1016/j.resplu.2023.100544

DO - 10.1016/j.resplu.2023.100544

M3 - Article (Academic Journal)

C2 - 38260121

SN - 2666-5204

VL - 17

JO - Resuscitation Plus

JF - Resuscitation Plus

M1 - 100544

ER -

Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3)

Abstract

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UN SDGs

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