Randomized trial of the i-gel supraglottic airway device versus tracheal intubation during out of hospital cardiac arrest (AIRWAYS-2): Patient outcomes at three and six months

Abstract

Aim: The AIRWAYS-2 cluster randomised controlled trial compared the i-gel supraglottic airway device (SGA) with tracheal intubation (TI) as the first advanced airway management (AAM) strategy used by Emergency Medical Service clinicians (paramedics) treating adult patients with non-traumatic out-of-hospital cardiac arrest (OHCA). It showed no difference between the two groups in the primary outcome of modified Rankin Scale (mRS) score at 30 days/hospital discharge. This paper reports outcomes to 6 months.Methods: Paramedics from four ambulance services in England were randomised 1:1 to use an i-gel SGA (759 paramedics) or TI (764 paramedics) as their initial approach to AAM. Adults who had a non-traumatic OHCA and were attended by a participating paramedic were enrolled automatically under a waiver of consent. Survivors were invited to complete questionnaires at three and six months after OHCA. Outcomes were analysed using regression methods.Results: 767/9296 (8.3%) enrolled patients survived to 30 days/hospital discharge and 317/767 survivors (41.3%) consented and were followed-up to six months. No significant differences were found between the two treatment groups in the primary outcome measure (mRS score: 3 months: odds ratio (OR) for good recovery (i-gel/TI, OR) 0.89, 95% CI 0.69À1.14; 6 months OR 0.91, 95% CI 0.71À1.16). EQ-5D-5L scores were also similar between groups and sensitivity analyses did not alter the findings. Conclusion:There were no statistically significant differences between the TI and i-gel groups at three and six months. We therefore conclude that the initially reported finding of no significant difference between groups at 30 days/hospital discharge was sustained when the period of follow-up was extended to six months.

Trend of Outcome Metrics in Recent Out-of-Hospital-Cardiac-Arrest Research: A Narrative Review of Clinical Trials

“…Up to 55% of survivors have poor functional outcome at 6 months, defined as a score of 4 to 6 on the modified Rankin scale [24]. Even among those survivors, the health-related quality-of-life score was ranked at a moderate level of 74-75 based on the EuroQol group's visual analogue scale, with the reference range of scores of 0-"the worst health you can imagine" to 100-"the best health you can imagine" [25]. While these tools provide valuable insight into the long-term outcomes of cardiac-arrest care, they may not be optimal outcomes for interventions that are aimed at short-term outcome measurements and should not be selected as the primary outcome in such studies.…”

“…It also points to the importance of an interconnected health system to capture and evaluate patients for longitudinal outcomes. Another advantage of an interconnected system is that it allows the evaluation of associated health care costs and resource utilization assessment [25]. Post-cardiac-arrest hospitalizations resulted in a high associated health care cost, with an increased length of stay, medical procedures, and systems of care [26].…”

Predefibrillation end-tidal CO2and defibrillation success in out-of-hospital cardiac arrest: an observational cohort study

“…Only then will we be able to gradually move away from the current algorithmic approach to ACLS management. Given the equivalent outcomes between the i-gel SGA and intubation,26 as well as its speed of insertion,27 the i-gel may be a suitable candidate for ETCO 2 measurement.…”

Cost-effectiveness of the i-gel supraglottic airway device compared to tracheal intubation during out-of-hospital cardiac arrest: Findings from the AIRWAYS-2 randomised controlled trial

“…This economic evaluation was an integral part of the largest RCT of airway management in OHCA to date, which incorporated automatic enrolment of all eligible patients to minimise bias. 10 , 25 We collected HRQoL data to six months, longer than most clinical trials in OHCA and exceeded the minimum of 90 days recommended in the core outcome set for cardiac arrest. 26 We believe this is the first trial-based cost-effectiveness analysis of an SGA with TI for first AAM for adults with non-traumatic OHCA.…”