Cindy Hein

Design of the RINSE Trial: The Rapid Infusion of cold Normal Saline by paramedics during CPR

BackgroundThe 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.Methods/DesignThis 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.DiscussionThis 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.Trial RegistrationClinicalTrials.gov: NCT01172678

A training program for novice paramedics provides initial laryngeal mask airway insertion skill and improves skill retention at 6 months.

Introduction: Major resuscitation councils endorse the use of the laryngeal mask airway (LMA) by paramedics for lifesaving airway interventions. Learning and maintaining adequate skill level is important for patient safety. The aim of this project was to develop a training program that provides student paramedics with initial knowledge and experience in LMA insertion skills but equally important to provide ongoing skill retention. Methods: After ethics approval and informed consent, 55 first year Paramedic degree students watched a manufacturers LMA instruction video and practiced insertion in three different part task trainers. Six months later, subjects were randomized to an intervention (reviewing the video and 10 minutes unsupervised practice) or control group before participating in a high-fidelity simulated clinical scenario. For equity of training, the control group received the intervention after the scenario. Main outcomes measured were time to insertion; success rate; and LMA skill retention (sum of LMA orientation; cuff inflation; bite block; securing; patient positioning; and overall subject performance). Results: Fifty subjects completed the study. Those in the intervention group displayed significantly shorter insertion times (P = 0.029), fewer attempts to achieve success (P = 0.033), and had significantly higher LMA skill performance levels (P = 0.019) at 6 months. Conclusions: We devised a short intervention based on our training program using a video and practice in part task trainers. In an assessment using high-fidelity simulation, we demonstrated significant improvements in maintenance of LMA insertion skills in student paramedics at 6 months. Our model of just-in-time assessment and reinforcement of training prevents skill decay and has implications for healthcare skills training in general.

Induction of therapeutic hypothermia during out-of-hospital cardiac arrest using a rapid infusion of cold saline: The RINSE Trial (Rapid Infusion of Cold Normal Saline)

Background: Patients successfully resuscitated by paramedics from out-of-hospital cardiac arrest often have severe neurologic injury. Laboratory and observational clinical reports have suggested that induction of therapeutic hypothermia during cardiopulmonary resuscitation (CPR) may improve neurologic outcomes. One technique for induction of mild therapeutic hypothermia during CPR is a rapid infusion of large-volume cold crystalloid fluid. Methods: In this multicenter, randomized, controlled trial we assigned adults with out-of-hospital cardiac arrest undergoing CPR to either a rapid intravenous infusion of up to 2 L of cold saline or standard care. The primary outcome measure was survival at hospital discharge; secondary end points included return of a spontaneous circulation. The trial was closed early (at 48% recruitment target) due to changes in temperature management at major receiving hospitals. Results: A total of 1198 patients were assigned to either therapeutic hypothermia during CPR (618 patients) or standard prehospital care (580 patients). Patients allocated to therapeutic hypothermia received a mean (SD) of 1193 (647) mL cold saline. For patients with an initial shockable cardiac rhythm, there was a decrease in the rate of return of a spontaneous circulation in patients who received cold saline compared with standard care (41.2% compared with 50.6%, P=0.03). Overall 10.2% of patients allocated to therapeutic hypothermia during CPR were alive at hospital discharge compared with 11.4% who received standard care (P=0.71). Conclusions: In adults with out-of-hospital cardiac arrest, induction of mild therapeutic hypothermia using a rapid infusion of large-volume, intravenous cold saline during CPR may decrease the rate of return of a spontaneous circulation in patients with an initial shockable rhythm and produced no trend toward improved outcomes at hospital discharge. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01173393.

Establishing the Aus-ROC Australian and New Zealand out-of-hospital cardiac arrest Epistry.

Introduction Out-of-hospital cardiac arrest (OHCA) is a global health problem with low survival. Regional variation in survival has heightened interest in combining cardiac arrest registries to understand and improve OHCA outcomes. While individual OHCA registries exist in Australian and New Zealand ambulance services, until recently these registries have not been combined. The aim of this protocol paper is to describe the rationale and methods of the Australian Resuscitation Outcomes Consortium (Aus-ROC) OHCA epidemiological registry (Epistry). Methods and analysis The Aus-ROC Epistry is designed as a population-based cohort study. Data collection started in 2014. Six ambulance services in Australia (Ambulance Victoria, SA Ambulance Service, St John Ambulance Western Australia and Queensland Ambulance Service) and New Zealand (St John New Zealand and Wellington Free Ambulance) currently contribute data. All OHCA attended by ambulance, regardless of aetiology or patient age, are included in the Epistry. The catchment population is approximately 19.3 million persons, representing 63% of the Australian population and 100% of the New Zealand population. Data are collected using Utstein-style definitions. Information incorporated into the Epistry includes demographics, arrest features, ambulance response times, treatment and patient outcomes. The primary outcome is ‘survival to hospital discharge’, with ‘return of spontaneous circulation’ as a key secondary outcome. Ethics and dissemination Ethics approval was independently sought by each of the contributing registries. Overarching ethics for the Epistry was provided by Monash University HREC (Approval No. CF12/3938—2012001888). A population-based OHCA registry capturing the majority of Australia and New Zealand will allow risk-adjusted outcomes to be determined, to enable benchmarking across ambulance providers, facilitate the identification of system-wide strategies associated with survival from OHCA, and allow monitoring of temporal trends in process and outcomes to improve patient care. Findings will be shared with participating ambulance services and the academic community.

Randomized comparison of the SLIPA (Streamlined Liner of the Pharynx Airway) and the SS-LM (Soft Seal Laryngeal Mask) by medical students

Objective:  The aim of the study was to compare the Streamlined Liner of the Pharynx Airway (SLIPA; Hudson RCI), a new supraglottic airway device, with the Soft Seal Laryngeal Mask (SS‐LM; Portex) when used by novices.

Description of the ambulance services participating in the Aus-ROC Australian and New Zealand out-of-hospital cardiac arrest Epistry

The present study aimed to describe and examine similarities and differences in the current service provision and resuscitation protocols of the ambulance services participating in the Aus‐ROC Australian and New Zealand out‐of‐hospital cardiac arrest (OHCA) Epistry. Understanding these similarities and differences is important in identifying ambulance service factors that might explain regional variation in survival of OHCA in the Aus‐ROC Epistry.

Regional variation in the characteristics, incidence and outcomes of out-of-hospital cardiac arrest in Australia and New Zealand: Results from the Aus-ROC Epistry

INTRODUCTION The aim of this study was to investigate regional variation in the characteristics, incidence and outcomes of out-of-hospital cardiac arrest (OHCA) in Australia and New Zealand. METHODS This was a population-based cohort study of OHCA using data from the Aus-ROC Australian and New Zealand OHCA Epistry over the period of 01 January 2015-31 December 2015. Seven ambulance services contributed data to the Epistry with a capture population of 19.8 million people. All OHCA attended by ambulance, regardless of aetiology or patient age, were included. RESULTS In 2015, there were 19,722 OHCA cases recorded in the Aus-ROC Epistry with an overall crude incidence of 102.5 cases per 100,000 population (range: 51.0-107.7 per 100,000 population). Of all OHCA cases attended by EMS (excluding EMS-witnessed cases), bystander CPR was performed in 41% of cases (range: 36%-50%). Resuscitation was attempted (by EMS) in 48% of cases (range: 40%-68%). The crude incidence for attempted resuscitation cases was 47.6 per 100,000 population (range: 34.7-54.1 per 100,000 population). Of cases with attempted resuscitation, 28% survived the event (range: 21%-36%) and 12% survived to hospital discharge or 30 days (range: 9%-17%; data provided by five ambulance services). CONCLUSION In the first results of the Aus-ROC Australian and New Zealand OHCA Epistry, significant regional variation in the incidence, characteristics and outcomes was observed. Understanding the system-level and public health drivers of this variation will assist in optimisation of the chain of survival provided to OHCA patients with the aim of improving outcomes.

Oxygen titration after resuscitation from out-of-hospital cardiac arrest: A multi-centre, randomised controlled pilot study (the EXACT pilot trial)

INTRODUCTION Recent studies suggest the administration of 100% oxygen to hyperoxic levels following return-of-spontaneous-circulation (ROSC) post-cardiac arrest may be harmful. However, the feasibility and safety of oxygen titration in the prehospital setting is unknown. We conducted a multi-centre, phase-2 study testing whether prehospital titration of oxygen results in an equivalent number of patients arriving at hospital with oxygen saturations SpO2 ≥ 94%. METHODS We enrolled unconscious adults with: sustained ROSC; initial shockable rhythm; an advanced airway; and an SpO2 ≥ 95%. Initially (Sept 2015-March 2016) patients were randomised 1:1 to either 2 L/minute (L/min) oxygen (titrated) or >10 L/min oxygen (control) via a bag-valve reservoir. However, one site experienced a high number of desaturations (SpO2 < 94%) in the titrated arm and this arm was changed (April 2016) to an initial reduction of oxygen to 4 L/min then, if tolerated, to 2 L/min, and the desaturation limit was decreased to <90%. RESULTS We randomised 61 patients to titrated (n = 37: 2L/min = 20 and 2-4 L/min = 17) oxygen or control (n = 24). Patients allocated to titrated oxygen were more likely to desaturate compared to controls ((SpO2 < 94%: 43% vs. 4%, p = 0.001; SpO2 < 90%: 19% vs. 4%, p = 0.09). The majority of desaturations (81%) occurred at 2L/min. On arrival at hospital the majority of patients had a SpO2 ≥ 94% (titrated: 90% vs. control: 100%) and all patients had a SpO2 ≥ 90%. One patient (control) re-arrested. Survival to hospital discharge was similar. CONCLUSION Oxygen titration post-ROSC is feasible in the prehospital environment, but incremental titration commencing at 4L/min oxygen flow may be needed to maintain an oxygen saturation >90% (NCT02499042).

Induction of Therapeutic Hypothermia During Out-of-Hospital Cardiac Arrest Using a Rapid Infusion of Cold SalineClinical Perspective

Background: Patients successfully resuscitated by paramedics from out-of-hospital cardiac arrest often have severe neurologic injury. Laboratory and observational clinical reports have suggested that induction of therapeutic hypothermia during cardiopulmonary resuscitation (CPR) may improve neurologic outcomes. One technique for induction of mild therapeutic hypothermia during CPR is a rapid infusion of large-volume cold crystalloid fluid. Methods: In this multicenter, randomized, controlled trial we assigned adults with out-of-hospital cardiac arrest undergoing CPR to either a rapid intravenous infusion of up to 2 L of cold saline or standard care. The primary outcome measure was survival at hospital discharge; secondary end points included return of a spontaneous circulation. The trial was closed early (at 48% recruitment target) due to changes in temperature management at major receiving hospitals. Results: A total of 1198 patients were assigned to either therapeutic hypothermia during CPR (618 patients) or standard prehospital care (580 patients). Patients allocated to therapeutic hypothermia received a mean (SD) of 1193 (647) mL cold saline. For patients with an initial shockable cardiac rhythm, there was a decrease in the rate of return of a spontaneous circulation in patients who received cold saline compared with standard care (41.2% compared with 50.6%, P=0.03). Overall 10.2% of patients allocated to therapeutic hypothermia during CPR were alive at hospital discharge compared with 11.4% who received standard care (P=0.71). Conclusions: In adults with out-of-hospital cardiac arrest, induction of mild therapeutic hypothermia using a rapid infusion of large-volume, intravenous cold saline during CPR may decrease the rate of return of a spontaneous circulation in patients with an initial shockable rhythm and produced no trend toward improved outcomes at hospital discharge. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01173393.

Induction of Therapeutic Hypothermia During Out-of-Hospital Cardiac Arrest Using a Rapid Infusion of Cold SalineClinical Perspective: The RINSE Trial (Rapid Infusion of Cold Normal Saline)

Background: Patients successfully resuscitated by paramedics from out-of-hospital cardiac arrest often have severe neurologic injury. Laboratory and observational clinical reports have suggested that induction of therapeutic hypothermia during cardiopulmonary resuscitation (CPR) may improve neurologic outcomes. One technique for induction of mild therapeutic hypothermia during CPR is a rapid infusion of large-volume cold crystalloid fluid. Methods: In this multicenter, randomized, controlled trial we assigned adults with out-of-hospital cardiac arrest undergoing CPR to either a rapid intravenous infusion of up to 2 L of cold saline or standard care. The primary outcome measure was survival at hospital discharge; secondary end points included return of a spontaneous circulation. The trial was closed early (at 48% recruitment target) due to changes in temperature management at major receiving hospitals. Results: A total of 1198 patients were assigned to either therapeutic hypothermia during CPR (618 patients) or standard prehospital care (580 patients). Patients allocated to therapeutic hypothermia received a mean (SD) of 1193 (647) mL cold saline. For patients with an initial shockable cardiac rhythm, there was a decrease in the rate of return of a spontaneous circulation in patients who received cold saline compared with standard care (41.2% compared with 50.6%, P=0.03). Overall 10.2% of patients allocated to therapeutic hypothermia during CPR were alive at hospital discharge compared with 11.4% who received standard care (P=0.71). Conclusions: In adults with out-of-hospital cardiac arrest, induction of mild therapeutic hypothermia using a rapid infusion of large-volume, intravenous cold saline during CPR may decrease the rate of return of a spontaneous circulation in patients with an initial shockable rhythm and produced no trend toward improved outcomes at hospital discharge. Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01173393.