Elsevier

Resuscitation

Volume 170, January 2022, Pages 1-10
Resuscitation

Clinical paper
Mechanical active compression-decompression versus standard mechanical cardiopulmonary resuscitation: A randomised haemodynamic out-of-hospital cardiac arrest study

https://doi.org/10.1016/j.resuscitation.2021.10.026Get rights and content

Abstract

Background

Active compression-decompression cardiopulmonary resuscitation (ACD-CPR) utilises a suction cup to lift the chest-wall actively during the decompression phase (AD). We hypothesised that mechanical ACD-CPR (Intervention), with AD up to 30 mm above the sternal resting position, would generate better haemodynamic results than standard mechanical CPR (Control).

Methods

This out-of-hospital adult non-traumatic cardiac arrest trial was prospective, block-randomised and non-blinded. We included intubated patients with capnography recorded during mechanical CPR. Exclusion criteria were pregnancy, prisoners, and prior chest surgery. The primary endpoint was maximum tidal carbon dioxide partial pressure (pMTCO2) and secondary endpoints were oxygen saturation of cerebral tissue (SctO2), invasive arterial blood pressures and CPR-related injuries. Intervention device lifting force performance was categorised as Complete AD (≥30 Newtons) or Incomplete AD (≤10 Newtons). Haemodynamic data, analysed as one measurement for each parameter per ventilation (Observation Unit, OU) with non-linear regression statistics are reported as mean (standard deviation). A two-sided p-value < 0.05 was considered as statistically significant.

Results

Of 221 enrolled patients, 210 were deemed eligible (Control 109, Intervention 101). The Control vs. Intervention results showed no significant differences for pMTCO2: 29(17) vs 29(18) mmHg (p = 0.86), blood pressures during compressions: 111(45) vs. 101(68) mmHg (p = 0.93) and decompressions: 21(20) vs. 18(18) mmHg (p = 0.93) or for SctO2%: 55(36) vs. 57(9) (p = 0.42). The 48 patients who received Complete AD in > 50% of their OUs had higher SctO2 than Control patients: 58(11) vs. 55(36)% (p < 0.001).

Conclusions

Mechanical ACD-CPR provided similar haemodynamic results to standard mechanical CPR. The Intervention device did not consistently provide Complete AD.

Clinical trial registration

ClinicalTrials.gov identifier (NCT number): NCT02479152. The Haemodynamic Effects of Mechanical Standard and Active Chest Compression-decompression During Out-of-hospital CPR.

Introduction

During cardiopulmonary resuscitation with active compression-decompression (ACD-CPR) the chest wall is actively lifted with a suction cup between compressions. This creates lower intrathoracic pressures in the decompression phase and improves cardiac output, via increased venous return, and perfusion to heart and brain tissue.1., 2. Clinical studies on manually-administered ACD-CPR have shown equal or improved end tidal carbon dioxide (EtCO2) and survival results.3., 4., 5., 6., 7., 8., 9. However, a Cochrane group suggested that the physical demands required to achieve effective ACD-CPR “may hinder in real practice the theoretical advantages of ACD-CPR over manual compressions”.8., 10.

A mechanical ACD-CPR device could overcome the issues with provider exhaustion.11., 12. In a porcine study Steinberg et al. used a modified piston-based device to compare standard mechanical CPR to mechanical ACD-CPR.13 They found that mechanical ACD-CPR improved cardiac output and cerebral blood flow, with a trend towards improved coronary perfusion pressures, despite similar capnometric readings.1., 13. While they used a 20 mm active decompression (AD) height above the sternal resting position, the optimal methods of delivering AD during ACD-CPR are not well defined in humans.14., 15.

We hypothesised that mechanical ACD-CPR (Intervention) with a device providing AD height up to 30 mm, would improve multi-modal haemodynamic measurements and provide a similar safety profile compared to standard mechanical piston-based CPR (Control) (both devices; Stryker, Lund, Sweden).

Section snippets

Study design and setting

This trial was prospective, cluster-randomised and un-blinded. All included patients were treated by the rapid response car (RRC) crew, covering an area of 822 km2 with 878,139 inhabitants. The RRC is manned 24/7 by an anaesthetist and a critical care paramedic, in the tiered response system of the emergency medical service (EMS) of Oslo and Akershus (Oslo University Hospital, Division of Prehospital Services, Norway).

Inclusion and exclusion

The RRC-crew identified inclusion and exclusion criteria and initiated the

Results

Between April 2015 and April 2017, the RRC-crew attended 722 of the 943 OHCA patients in the region. Of these, 221 met the inclusion criteria and were treated with either the Control or the Intervention device, while 501 did not met the inclusion criteria due to ROSC or CPR stopped due to futility. Eleven patients were subsequently excluded, leaving 210 in the intention to treat (ITT) groups: Control 109 and Intervention 101 (Fig. 1).

Main findings

This is the first clinical trial of mechanical ACD-CPR. In 210 patients with OHCA, the haemodynamic measures and clinical outcomes were not significantly different between the Control and Intervention groups. No difference in injuries was found. Not all Intervention patients received Complete AD, and this may have affected overall results. An exploratory analysis found that, within the Intervention group, Complete AD provided significantly higher SctO2 and CBPpeak and lower pMTCO2 and DBPnadir

Conclusions

This first study of mechanical ACD-CPR found no overall difference in haemodynamic readings, clinical outcomes, or frequency of CPR-related injuries compared with standard mechanical CPR. The Intervention device provided inconsistent delivery of the intended ACD-CPR pattern, and this may have influenced results. A study with an optimised device is feasible and warranted to investigate the clinical impact of mechanical ACD-CPR on ROSC and survival.

Funding

This trial was funded by a grant from Stryker (formerly Physio-Control), the manufacturer of the study devices, to cover Oslo University Hospital salary for a study coordinator (50% during the data collection period), the research devices and development and cost for CRF and data handling. The PI developed the LUCAS 2-AD trial protocol in consultation with Physio-Control, staff at the data coordinating centre, and the statistician. Norwegian National Advisory Unit on Prehospital Emergency

CRediT authorship contribution statement

Per Olav Berve: Data curation, Formal analysis, Investigation, Software, Supervision, Visualisation, Writing - original draft. Bjarne Madsen Hardig: Data curation. Tore Skålhegg: Data curation. Håvard kongsgaard: Formal analysis. Jo kramer Johansen: Writing - original draft. Lars Wik: Conceptualization, Funding acquisition, Methodology, Project administration.

Declaration of Competing Interest

LW was PI in the Zoll Medical funded CIRC study and holds patents via Oslo University Hospital (Inven2). He is a member of the medical advisory board of Stryker/Physio-Control. At the time of the study, BMH was employed by Stryker/Jolife AB, which manufactures the LUCAS device, LIFEPAK 15 and CODE-STAT. In addition, JC did analysis and data work for the study that was funded by Stryker/Jolife AB. POB, TS, HK and JKJ declare no conflicts of interests.

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