TAME Cardiac Arrest is a phase III, multi-centre, randomised, parallel-group, controlled trial to determine whether targeted therapeutic mild hypercapnia (TTMH) improves neurological outcome at 6 months compared to standard care (targeted normocapnia, TN) in resuscitated cardiac arrest patients who are admitted to the intensive care unit.
The hypothesis being evaluated is that, in resuscitated cardiac arrest patients admitted to ICU, TTMH improves neurological outcome at 6 months as assessed by the Glasgow Outcomes Scale Extended (GOSE) method. Fully eligible patients enrolled into this trial will be allocated to a TTMH protocol (target PaCO2 range 50 – 55 mmHg) or the Standard Care protocol (target PaCO2 range 35 – 45 mmHg) for 24 hours following randomisation. Patients in each group will be sedated to achieve moderate to deep sedation (a target Richmond Agitation Sedation Scale of -4). Arterial blood gas (ABG) and end-tidal carbon dioxide (ETCO2) levels will be measured at baseline and then used to guide respiratory rate adjustments of minute ventilation to remain within their target PaCO2 range. Importantly, ventilation management for all patients will be guided by ABG data assessed after adjustment to 37oC (alpha-stat) and, to ensure safety, the treating ICU physician can modify patients management, including the use of sedative agents, muscle relaxants and paralysis, as clinically indicated throughout the 24-hour intervention period. After the 24-hour intervention period, for patients allocated to TTMH, it is recommended that restoration of normocapnia occur slowly over the subsequent 4-hours (study time period 24 – 28 hours) facilitated by the use of ABG samples and ETCO2 levels to guide respiratory rate adjustments.