Mechanical devices. Prof Gavin Perkins University of Warwick Heart of England NHS Foundation Trust

Transcription

1 Mechanical devices Prof Gavin Perkins University of Warwick Heart of England NHS Foundation Trust

2 Academic Conflict of interest National Institute for Health Research Health Technology Assessment Programme Commercial None Disclaimer: This talk presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health

3 High quality CPR High quality CPR critical for best outcomes Challenging Multiple tasks Limited team Fatigue Transport

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5 ILCOR recommendations 2010 There are insufficient data to support or refute the routine use of load-distributing band CPR, LUCAS CPR, or mechanical piston CPR, instead of standard CPR. On the basis of case reports and case series it may be reasonable to consider LDB or LUCAS CPR to maintain continuous chest compressions while the patient undergoes percutaneous coronary intervention (PCI) or computed tomography (CT) or similar diagnostic studies when provision of manual CPR would be difficult.

6 Autopulse

7 ASPIRE trial (autopulse) Autopulse (n=554), Manual CPR (n=517) % survival P=0.06 P=0.006 Hallstrom A et al JAMA 2006

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9 (1) 4 hours training, continuous monitoring for protocol compliance. (2) Pre-trial simulation study of provider compliance with the trial protocol. (3) Three distinct study phases (infield training, run-in, and statistical inclusion) (4) Monitoring of the CPR process (5) Randomization at the subject level after the decision to resuscitate (6) Use of the Group Sequential Double Triangular Test with sufficient power to determine superiority, inferiority, or equivalence.

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11 CIRC trial

12 CIRC trial

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14 LUCAS-2 Mechanical compression device 4-5 cm depth; rate 100 min -1 Equal compression / decompression Full chest recoil Battery powered Continuous or 30:2 ratio

15 LINC trial A multicenter, randomized, controlled trial designed to evaluate the efficacy and safety of: LUCAS concept for resuscitation of OHCA including defibrillation during ongoing compressions vs. manual CPR according to 2005 guidelines Rubertssen JAMA 2013

16 LINC TRIAL

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19 4-hour survival: Risk difference -0.05% 95% C.I , p=1.00 Outcome 4-hour survival 23.6% 23.7%

20 Authors conclusion In clinical practice, mechanical CPR using the presented algorithm did not result in improved effectiveness compared with manual CPR

21 Pre-hospital Randomised Assessment of a Mechanical Compression Device In Cardiac Arrest (PARAMEDIC) Study

22 Acknowledgements West Midlands Ambulance Service: Dr Andy Carson, Gill Price, Phil Hallam, Ian Jones, Mike Smyth, Garry Parcell, Andy Rosser, Kate Wilson, Emma Harris, Matt Ward South Central Ambulance Service: Prof Charles Deakin, Ian Teague, Ed England, Helen Pocock, Helen Rooke, Nikki Brock, Dr John Black, Phil Turton North East Ambulance Service: Dr Kyee Han, Dr John Wright, Paul Fell, Laura Blair, Gary Shaw, Sonia Byers, Graham McClelland, Kevin Hamilton Welsh Ambulance Service: Richard Whitfield, Amanda Williams, Rebecca Jones, Jane Turner, Andrew Jenkins, Kevin Webb, Karen Pitt University of Warwick: Prof Gavin Perkins, Prof Simon Gates, Dr Ranjit Lall, Prof Matthew Cooke, Jessica Horton, Vikki Gordon, Sam Brace- McDonnell, Hayley Johnson, Inga Ruders, Sonia Davis, Sarah Rumble, Kate Packard, Bev Hoddell, Nikki Morrow, Dr Sarah Duggan, Susie Hennings, Dr Anne-Marie Slowther, Prof Sallie Lamb University of Leeds: Prof Chris McCabe, Prof Claire Hulme, Charlotte Kelly University of Surrey: Prof Tom Quinn University of Coventry: Prof Malcolm Woollard NIHR- HTA: Nick Eaton NIHR Clinical Research Network: Julie Norris Trial Steering Committee: Prof Jon Nicholl, Prof Helen Snooks, Dr Fionna Moore, Dr Alasdair Gray, Martyn Box, Father Neil Bayliss, John Long Data Monitoring Committee: Prof Marion Campbell, Prof Kathy Rowan, Dr Jerry Nolan

23 Study design Pragmatic, multi-centre, cluster randomised, clinical effectiveness trial P opulation: Adults, non-traumatic OHCA I ntervention: LUCAS CPR C omparator: Standard CPR O utcome: 30 day survival, clinical and cost effectiveness Protocol: Perkins GD et al Scand J Trauma Resusc Emerg Med. 2010

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25 Randomisation ratio 1 LUCAS to 2 Control LUCAS MANUAL CPR

26 Patient eligibility Inclusion criteria: i. Cardiac arrest was out of hospital; ii. iii. iv. The first ambulance resource was a trial vehicle; Known or believed to be age 18 years or over; Resuscitation attempted was initiated by the attending ambulance clinicians according to JRCALC guidelines Exclusion criteria: i. Cardiac arrest caused by trauma; ii. Known or clinically apparent pregnancy.

27 Sample size Original sample size 80% power, an increase in the incidence of survival to 30 days from 5% in the manual compression group to 7.5% in the LUCAS group n = 3675 participants DMEC revised sample size (Sept 2012) Sample size increased 4400

28 PRIMARY Outcomes 30 day survival (after cardiac arrest) SECONDARY Survival event (sustained ROSC) Survival to 3 months and 12 months Neurological outcome (CPC) at 3 months SUB-GROUPS Witnessed, Bystander CPR, Vehicle, Site, Age, Presumed cardiac, EMS response time

29 Ambulance Service Number vehicles randomised West Midlands 229 Wales 88 South Central 62 North East 39

30 Resus attempted Assessed for Eligibility (n= 4689) Randomised =4471 Excluded (n=218) Some cases fall under more than 1 category: In hospital cardiac arrest n=9 Traumatic arrest n=107 Age < 18 n=107 Pregnant n=2 LUCAS n=1652 Manual CPR n=2819 LUCAS n= 985 (59.6%) Manual CPR n=638 (38.6%) Unknown = 29 (1.7%) Manual CPR n=2808 (99.6%) LUCAS n=11 (0.4%) Follow-up n=1652 (100%) Lost to follow-up n=0 (0%) Follow-up n=2818 (99.9%) Lost to follow-up n=1 (0.04%)

31 LUCAS (n=1652) Control (n=2819) Age, years (mean, sd) 71.0 (16.3) 71.6 (16.1) Gender (male) 1039 (63.0%) 1774 (62.9%) Presumed Cardiac 1417 (85.8%) 2445 (86.7%) Home 1336 (80.9%) 2336 (82.9%) Public place 225 (13.6%) 362 (12.6%) Response time, mins (mean, sd) 7.6 (5.2) 8.2 (13.3) Bystander witnessed 710 (42.9%) 1234 (43.7%) Bystander CPR 716 (43.3%) 1238 (43.9%) VF/VT 376 (22.8%) 615 (21.8%) PEA/asystole 1222 (74.0%) 2091 (74.2%)

32 LUCAS (n=1652) Control (n=2819) Transport to hospital 1099 (66.5%) 1868 (66.2%) ROSC 377 (22.8%) 658 (23.3%) CPR in progress 640 (38.7%) 1081 (38.4%) Unknown 82 (5.0%) 129 (4.6%)

33 No difference in 30 day survival Unadjusted odds ratio = 0.91 (95% CI: 0.71, 1.17) P=0.473 Adjusted odds ratio = 0.86 (95% CI: 0.64, 1.15) P=0.31 %

34 Secondary outcomes CPC Unadjusted odds ratio = 0.77 (95% CI = 0.59, 1.02) P= CPC Adjusted odds ratio= 0.72 (95% CI = 0.52, 0.99) P= % *

35 Sub-group analysis (rhythm) Odds ratio = 0.71 (95% CI 0.52, 0.98) Odds ratio= 1.38 (95% CI 0.80, 2.36) % 30 day survival

36 Conclusion In a large, independent, clinical effectiveness trial, we found no statistical difference in 30 day survival between LUCAS and manual CPR The rate of survival with a CPC score of 1/2 was 1.3% lower in the LUCAS arm Sub-group analysis identified lower survival in patients who had an initially shockable rhythm

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38 RCT start high, obs. data start low P I C O Outcome Outcome Outcome Outcome Systematic review Critical Critical Important Not Summary of findings & estimate of effect for each outcome High Moderate Low Very low Grade down Grade up 1. Risk of bias 2. Inconsistency 3. Indirectness 4. Imprecision 5. Publication bias 1. Large effect 2. Dose response 3. Confounders Guideline development Formulate recommendations: For or against (direction) Strong or weak (strength) By considering: Quality of evidence Balance benefits/harms Values and preferences Revise if necessary by considering: Resource use (cost) Rate overall quality of evidence across outcomes based on lowest quality of critical outcomes We recommend using We suggest using We recommend against using We suggest against using

39 COSTR 2015? Recommend against the routine deployment of mechanical CPR devices for OHCA This assessment considers the costs of mechanical CPR purchase, maintenance and training alongside absence of any evidence of superiority Continue to have a role where manual CPR is difficult or impossible Transport, Catheter lab, CT, Bridge to transplant Further research in-hospital CPR