Cluster randomised comparison of the effectiveness of 100% oxygen versus titrated oxygen in patients with a sustained return of spontaneous circulation following out of hospital cardiac arrest: a feasibility study. PROXY: post ROSC OXYgenation study.

BACKGROUND: Hyperoxia following out of hospital cardiac arrest (OHCA) is associated with a poor outcome. Animal data suggest the first hour post resuscitation may be the most important. In the UK the first hour usually occurs in the prehospital environment.

METHODS: A prospective controlled trial, cluster randomised by paramedic, comparing titrated oxygen with 100% oxygen for the first hour after return of spontaneous circulation (ROSC) following OHCA. The trial was done in a single emergency medical services (EMS) system in the United Kingdom (UK) admitting patients to three emergency departments. This was a feasibility trial to determine whether EMS staff (UK paramedics) can be successfully recruited and deliver the intervention.

RESULTS: One hundred and fifty seven paramedics were approached and 46 (29%) were consented, randomised and trained. During the study period 624 patients received a resuscitation attempt. A study paramedic was in attendance at 73 (12%) of these active resuscitations. Thirty-five patients were recruited to the trial, 32 (91%) were transported to hospital and 13 (37%) survived to 90 days. The intervention was initiated in 27/35 (77%) of enrolled patients. A reliable oxygen saturation trace was obtained in 22/35 (69%) of patients. Data collection was complete in 33/35 (94%) of patients.

CONCLUSIONS: It may be feasible to complete a randomised trial of titrated versus unrestricted oxygen in the first hour after ROSC following OHCA in the UK. However, the relatively few eligible patients and incomplete initiation of the allocated intervention are challenges to future research.

TRIAL REGISTRATION: ISRCTN 49548506 retrospectively registered on 24.11.2016.