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A trial of an impedance threshold device in out-of-hospital cardiac arrest.

ABSTRACT: The impedance threshold device (ITD) is designed to enhance venous return and cardiac output during cardiopulmonary resuscitation (CPR) by increasing the degree of negative intrathoracic pressure. Previous studies have suggested that the use of an ITD during CPR may improve survival rates after cardiac arrest.We compared the use of an active ITD with that of a sham ITD in patients with out-of-hospital cardiac arrest who underwent standard CPR at 10 sites in the United States and Canada. Patients, investigators, study coordinators, and all care providers were unaware of the treatment assignments. The primary outcome was survival to hospital discharge with satisfactory function (i.e., a score of ?3 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating greater disability).Of 8718 patients included in the analysis, 4345 were randomly assigned to treatment with a sham ITD and 4373 to treatment with an active device. A total of 260 patients (6.0%) in the sham-ITD group and 254 patients (5.8%) in the active-ITD group met the primary outcome (risk difference adjusted for sequential monitoring, -0.1 percentage points; 95% confidence interval, -1.1 to 0.8; P=0.71). There were also no significant differences in the secondary outcomes, including rates of return of spontaneous circulation on arrival at the emergency department, survival to hospital admission, and survival to hospital discharge.Use of the ITD did not significantly improve survival with satisfactory function among patients with out-of-hospital cardiac arrest receiving standard CPR. (Funded by the National Heart, Lung, and Blood Institute and others; ROC PRIMED ClinicalTrials.gov number, NCT00394706.).

SUBMITTER: Aufderheide TP

PROVIDER: S-EPMC3204381 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature

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A trial of an impedance threshold device in out-of-hospital cardiac arrest.

Aufderheide Tom P TP Nichol Graham G Rea Thomas D TD Brown Siobhan P SP Leroux Brian G BG Pepe Paul E PE Kudenchuk Peter J PJ Christenson Jim J Daya Mohamud R MR Dorian Paul P Callaway Clifton W CW Idris Ahamed H AH Andrusiek Douglas D Stephens Shannon W SW Hostler David D Davis Daniel P DP Dunford James V JV Pirrallo Ronald G RG Stiell Ian G IG Clement Catherine M CM Craig Alan A Van Ottingham Lois L Schmidt Terri A TA Wang Henry E HE Weisfeldt Myron L ML Ornato Joseph P JP Sopko George G

The New England journal of medicine 20110901 9

<h4>Background</h4>The impedance threshold device (ITD) is designed to enhance venous return and cardiac output during cardiopulmonary resuscitation (CPR) by increasing the degree of negative intrathoracic pressure. Previous studies have suggested that the use of an ITD during CPR may improve survival rates after cardiac arrest.<h4>Methods</h4>We compared the use of an active ITD with that of a sham ITD in patients with out-of-hospital cardiac arrest who underwent standard CPR at 10 sites in the ...[more]

PMID: 21879897

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Project description:BackgroundCerebral hypoperfusion may aggravate neurological damage after cardiac arrest. Near-infrared spectroscopy (NIRS) provides information on cerebral oxygenation but its relevance during post-resuscitation care is undefined. We investigated whether cerebral oxygen saturation (rSO2) measured with NIRS correlates with the serum concentration of neuron-specific enolase (NSE), a marker of neurological injury, and with clinical outcome in out-of-hospital cardiac arrest (OHCA) patients.MethodsWe performed a post hoc analysis of a randomised clinical trial (COMACARE, NCT02698917) comparing two different levels of carbon dioxide, oxygen and arterial pressure after resuscitation from OHCA with ventricular fibrillation as the initial rhythm. We measured rSO2 in 118 OHCA patients with NIRS during the first 36 h of intensive care. We determined the NSE concentrations from serum samples at 48 h after cardiac arrest and assessed neurological outcome with the Cerebral Performance Category (CPC) scale at 6 months. We evaluated the association between rSO2 and serum NSE concentrations and the association between rSO2 and good (CPC 1-2) and poor (CPC 3-5) neurological outcome.ResultsThe median (inter-quartile range (IQR)) NSE concentration at 48 h was 17.5 (13.4-25.0) μg/l in patients with good neurological outcome and 35.2 (22.6-95.8) μg/l in those with poor outcome, p < 0.001. We found no significant correlation between median rSO2 and NSE at 48 h, rs = - 0.08, p = 0.392. The median (IQR) rSO2 during the first 36 h of intensive care was 70.0% (63.5-77.0%) in patients with good outcome and 71.8% (63.3-74.0%) in patients with poor outcome, p = 0.943. There was no significant association between rSO2 over time and neurological outcome. In a binary logistic regression model, rSO2 was not a statistically significant predictor of good neurological outcome (odds ratio 0.99, 95% confidence interval 0.94-1.04, p = 0.635).ConclusionsWe found no association between cerebral oxygenation measured with NIRS and NSE concentrations or outcome in patients resuscitated from OHCA.Trial registrationClinicalTrials.gov, NCT02698917 . Registered on 26 January 2016.

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A trial of an impedance threshold device in out-of-hospital cardiac arrest.

Publications

A trial of an impedance threshold device in out-of-hospital cardiac arrest.

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