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Design of the RINSE trial: the rapid infusion of cold normal saline by paramedics during CPR.

ABSTRACT: The International Liaison Committee on Resuscitation (ILCOR) now recommends therapeutic hypothermia (TH) (33 °C for 12-24 hours) as soon as possible for patients who remain comatose after resuscitation from shockable rhythm in out-of-hospital cardiac arrest and that it be considered for non shockable rhythms. The optimal timing of TH is still uncertain. Laboratory data have suggested that there is significantly decreased neurological injury if cooling is initiated during CPR. In addition, peri-arrest cooling may increase the rate of successful defibrillation. This study aims to determine whether paramedic cooling during CPR improves outcome compared standard treatment in patients who are being resuscitated from out-of-hospital cardiac arrest.This paper describes the methodology for a definitive multi-centre, randomised, controlled trial of paramedic cooling during CPR compared with standard treatment. Paramedic cooling during CPR will be achieved using a rapid infusion of large volume (20-40 mL/kg to a maximum of 2 litres) ice-cold (4 °C) normal saline.The primary outcome measure is survival at hospital discharge. Secondary outcome measures are rates of return of spontaneous circulation, rate of survival to hospital admission, temperature on arrival at hospital, and 12 month quality of life of survivors.This trial will test the effect of the administration of ice cold saline during CPR on survival outcomes. If this simple treatment is found to improve outcomes, it will have generalisability to prehospital services globally.ClinicalTrials.gov: NCT01172678.

SUBMITTER: Deasy C

PROVIDER: S-EPMC3207909 | biostudies-literature | 2011 Oct

REPOSITORIES: biostudies-literature

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Design of the RINSE trial: the rapid infusion of cold normal saline by paramedics during CPR.

Deasy Conor C Bernard Stephen S Cameron Peter P Jacobs Ian I Smith Karen K Hein Cindy C Grantham Hugh H Finn Judith J

BMC emergency medicine 20111013

<h4>Background</h4>The International Liaison Committee on Resuscitation (ILCOR) now recommends therapeutic hypothermia (TH) (33 °C for 12-24 hours) as soon as possible for patients who remain comatose after resuscitation from shockable rhythm in out-of-hospital cardiac arrest and that it be considered for non shockable rhythms. The optimal timing of TH is still uncertain. Laboratory data have suggested that there is significantly decreased neurological injury if cooling is initiated during CPR. ...[more]

PMID: 21995804

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Project description:ImportanceFew high-quality studies have clarified whether hypertonic saline is best administered as slow continuous infusion (SCI) therapy or rapid intermittent bolus (RIB) therapy for symptomatic severe hyponatremia.ObjectiveTo compare the risk of overcorrection in RIB and SCI with hypertonic saline in patients with symptomatic hyponatremia.Design, setting, and participantsThis prospective, investigator-initiated, multicenter, open-label, randomized clinical trial enrolled 178 patients older than 18 years with moderately severe to severe hyponatremia and glucose-corrected serum sodium (sNa) levels of 125 mmol/L or less. Recruitment took place from August 24, 2016, until August 21, 2019, across emergency departments and wards of 3 general hospitals in the Republic of Korea.InterventionsEither RIB or SCI of hypertonic saline, 3%, for 24 to 48 hours stratified by the severity of clinical symptoms.Main outcome and measuresThe primary outcome was overcorrection at any given period, defined as increase in the sNa level by greater than 12 or 18 mmol/L within 24 or 48 hours, respectively. Secondary and post hoc outcomes included efficacy and safety of the treatment approaches. The sNa concentrations were measured every 6 hours for 2 days.ResultsThe 178 patients (mean [SD] age, 73.1 [12.2] years; 80 (44.9%) male; mean [SD] sNa concentrations, 118.2 [5.0] mmol/L) were randomly assigned to the RIB group (n = 87) or the SCI group (n = 91). Overcorrection occurred in 15 of 87 (17.2%) and 22 of 91 (24.2%) patients in the RIB and SCI groups, respectively (absolute risk difference, -6.9% [95% CI, -18.8% to 4.9%]; P = .26). The RIB group showed lower incidence of relowering treatment than the SCI group (36 of 87 [41.4%] vs 52 of 91 [57.1%] patients, respectively; absolute risk difference, -15.8% [95% CI, -30.3% to -1.3%]; P = .04; number needed to treat, 6.3). Groups did not differ in terms of efficacy in increasing sNa concentrations nor improving symptoms, but RIB, when compared with SCI, showed better efficacy in achieving target correction rate within 1 hour (intention-to-treat analysis: 28 of 87 (32.2%) vs 16 of 91 (17.6%) patients, respectively; absolute risk difference, 14.6% [95% CI, 2%-27.2%]; P = .02; number needed to treat, 6.8; per-protocol analysis: 21 of 72 (29.2%) vs 12 of 73 (16.4%) patients, respectively; absolute risk difference, 12.7% [95% CI, -0.8% to 26.2%]; P = .07). The statistical significance of the intention-to-treat and per-protocol analyses were similar for all outcomes except for achieving the target correction rate within 1 hour.Conclusions and relevanceThis randomized clinical trial found that both RIB and SIC therapies of hypertonic saline for treating hyponatremia were effective and safe, with no difference in the overcorrection risk. However, RIB had a lower incidence of therapeutic relowering treatment and tended to have a better efficacy in achieving sNa within 1 hour than SCI. RIB could be suggested as the preferred treatment of symptomatic hyponatremia, which is consistent with the current consensus guidelines.Trial registrationClinicalTrials.org Identifier: NCT02887469.

Project description:INTRODUCTION:Endotracheal suction (ETS) is a frequent and necessary airway intervention for the intubated child. The aim of ETS is to clear the endotracheal tube and airways of respiratory secretions; however, the methods of performing ETS are varied. Internationally a number of ETS treatments are in use. Many have not been rigorously evaluated in a randomised controlled trial setting, and it is uncertain whether any are associated with better outcomes for the critically ill child. With approximately 50% of paediatric intensive care admissions requiring intubation, ETS interventions that maximise the efficacy and minimise the complications of ETS could translate to improved health for substantial numbers of critically ill children, and significant cost savings. The primary aim of the study is to examine two ETS interventions, normal saline instillation and lung recruitment, to determine if it is feasible to conduct a full efficacy trial. METHODS AND ANALYSIS:NARES (Normal saline instillation versus no normal saline instillation And lung Recruitment versus no lung recruitment with paediatric Endotracheal Suction) is a single-centre, pilot, factorial randomised controlled trial conducted in a tertiary referral paediatric centre in Brisbane, Australia. Children (aged 0-16 years) are eligible if they are intubated with an endotracheal tube and mechanically ventilated. Two intervention pairs will be compared using a 2×2 factorial design: (1) normal saline instillation versus no normal saline instillation; and (2) lung recruitment versus no lung recruitment. The primary outcome is study feasibility measured by a composite analysis of eligibility, recruitment, retention, protocol adherence and missing data. Secondary outcomes are ventilator-associated pneumonia, SpO2/FiO2 ratio, lung compliance, end expiratory level and regional tidal volume. ETHICS AND DISSEMINATION:Ethical approval to conduct the research has been obtained. Dissemination of the research findings will be untaken, guided by the Consolidated Standards of Reporting Trials statement recommendations. Protocol content was guided by the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. TRIAL REGISTRATION NUMBER:ACTRN12617000609358; Pre-results.

Project description:BackgroundThe benefits of cardiopulmonary resuscitation training for schoolchildren are well known, but the appropriate age for introducing training is still being discussed. This is a very important issue, since out-of-hospital cardiac arrest is a major public health concern. The objective of this study was to investigate the effects of implemented cardiopulmonary resuscitation training on the knowledge of schoolchildren in the last three grades of Slovenian elementary schools and theirs willingness, attitudes, and intentions toward helping others and performing cardiopulmonary resuscitation. The experience of training instructors was also explored.MethodsA mixed methods research design was employed, using a Separate Pre-Post Samples Design and focus groups. Research was conducted in 15 Slovenian public elementary schools offering cardiopulmonary resuscitation training. Focus groups included training instructors and developers. Data was collected with a structured questionnaire from April to June 2018 and analyzed using univariate and bivariate analyses. The three focus groups were convened in September and October 2018. Content analysis of the discussion transcriptions was conducted. The sample included 764 schoolchildren aged 12.5–14.5?years before cardiopulmonary resuscitation training and 566 schoolchildren after training. Three non-homogeneous focus groups included eight cardiopulmonary resuscitation instructors.ResultsSignificant progress in cardiopulmonary resuscitation knowledge was noted after training implementation, with the greatest progress seen in the youngest age group (mean age 12.5). The greatest increase after training was seen for the variables Attitude toward helping others (p?=?0.001) and Self-confidence (p?=?0.001). Analysis of the focus groups yielded two themes: (a) the effects of cardiopulmonary resuscitation training on schoolchildren, and (b) the systemic responsibility of the school system and professional bodies.ConclusionsSignificant progress in schoolchildren’s cardiopulmonary resuscitation knowledge after training was established. Early introduction of training is recommended. Cardiopulmonary resuscitation knowledge raises awareness of the responsibility to help others and increases self-confidence to provide bystander cardiopulmonary resuscitation. It can be concluded that early cardiopulmonary resuscitation training for children is crucial. It should be a mandatory part of school curricula in those countries where cardiopulmonary resuscitation is not yet mandatory.

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Design of the RINSE trial: the rapid infusion of cold normal saline by paramedics during CPR.

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Design of the RINSE trial: the rapid infusion of cold normal saline by paramedics during CPR.

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