Abstract
Active compression-decompression cardiopulmonary resuscitation (CPR) with decreased intrathoracic pressure in the decompression phase can lead to improved haemodynamics compared with standard CPR. We aimed to assess effectiveness and safety of this intervention on survival with favourable neurological function after out-of-hospital cardiac arrest. In our randomised trial of 46 emergency medical service agencies (serving 2·3 million people) in urban, suburban, and rural areas of the USA, we assessed outcomes for patients with out-of-hospital cardiac arrest according to Utstein guidelines. We provisionally enrolled patients to receive standard CPR or active compression-decompression CPR with augmented negative intrathoracic pressure (via an impedance-threshold device) with a computer-generated block randomisation weekly schedule in a one-to-one ratio. Adults (presumed age or age ≥18 years) who had a non-traumatic arrest of presumed cardiac cause and met initial and final selection criteria received designated CPR and were included in the final analyses. The primary endpoint was survival to hospital discharge with favourable neurological function (modified Rankin scale score of ≤3). All investigators apart from initial rescuers were masked to treatment group assignment. This trial is registered with ClinicalTrials.gov, number NCT00189423. 2470 provisionally enrolled patients were randomly allocated to treatment groups. 813 (68) of 1201 patients assigned to the standard CPR group (controls) and 840 (66) of 1269 assigned to intervention CPR received designated CPR and were included in the final analyses. 47 (6) of 813 controls survived to hospital discharge with favourable neurological function compared with 75 (9) of 840 patients in the intervention group (odds ratio 1·58, 95 CI 1·07-2·36; p=0·019]. 74 (9) of 840 patients survived to 1 year in the intervention group compared with 48 (6) of 813 controls (p=0·03), with equivalent cognitive skills, disability ratings, and emotional-psychological statuses in both groups. The overall major adverse event rate did not differ between groups, but more patients had pulmonary oedema in the intervention group (94 [11] of 840) than did controls (62 [7] of 813; p=0·015). On the basis of our findings showing increased effectiveness and generalisability of the study intervention, active compression-decompression CPR with augmentation of negative intrathoracic pressure should be considered as an alternative to standard CPR to increase long-term survival after cardiac arrest. US National Institutes of Health grant R44-HL065851-03, Advanced Circulatory Systems.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 301-311 |
| Number of pages | 11 |
| Journal | The Lancet |
| Volume | 377 |
| Issue number | 9762 |
| DOIs | |
| State | Published - 2011 |
Bibliographical note
Funding Information:We thank the many first responders, firefighters, emergency medical technicians, and paramedics at all sites who took care of the patients, and without whom survival from out-of-hospital cardiac arrest would not be possible (see webappendix pp 5–9 ). The study was funded by the US National Institutes of Health and the federal grant ( R44-HL065851-03 ) was used by Advanced Circulatory Systems to fund the study.
Funding Information:
TPA, RJF, MAW, BDM, RAS, RMD, and MLO all received grant funds to their respective institutions for services related to patient enrolment, follow-up and data management for this clinical study; RGH received consulting fees for statistical analyses (US National Institutes of Health [NIH] R44-HL065851-03 ). KGL was co-inventor of the impedance-threshold device and active compression-decompression cardiopulmonary resuscitation device, and founded Advanced Circulatory Systems in 1997 after the University of Minnesota (MN, USA) declined the opportunity to apply for patent protection on the impedance threshold device. All investigators feel KGL contributed substantially to this study and therefore should be listed as an author rather than incorporating his role within the activities of the sponsor, Advanced Circulatory Systems. In his role as the Chief Medical Officer of Advanced Circulatory Systems, KGL participated with the other investigators in obtaining the NIH grant funding (KGL was the principal investigator on the Small Business Innovation Research grant), the study design, data interpretation, writing and the decision to submit the paper for publication. KGL was not involved in any patient care or assessment of patient neurological status during the 1-year follow-up. Outside the present study, TPA has board membership for Take Heart America and Citizen CPR Foundation, has consulted for JoLife Medical and Medtronic Foundation, and has received grants/grants pending from the NIH Immediate Trial, NIH Resuscitation Outcomes Consortium, NIH Neurological Emergency Treatment Trials Network, and NIH Medical College of Wisconsin K12 Research Career Development Program. RJF has received payment for one lecture from Advanced Circulatory Systems. MAW has consulted for Baxter and Vitacare, has received grants/grants pending from the NIH Immediate Trial, payment for lectures or speakers' bureau membership from Vitacare and Sub Zero, and royalties from Cook Critical Care. BDM has board membership for Take Heart Minnesota and has received grants/grants pending from the NIH Neurological Emergency Treatment Trials Network. DET has received grants/grants pending from the Predict HD study , NINDS-6375 , NINDS-40068 and NIMH-01579 , and royalties as a textbook editor.