None listed
Conditions
Brief summary
In animal models, exposure to high levels of oxygen after cardiac arrest worsens neurological outcome. However, clinical data are limited, and standard care of patients after cardiac arrest includes exposure to abnormally high levels of oxygen for prolonged periods. In this RCT, 42 patients resuscitated from community cardiac arrest will receive either standard therapy with high concentration oxygen or careful titration of oxygen to avoid either abnormally high or low oxygen levels. The feasibility study will be undertaken in Auckland, Wellington, and Christchurch. This study will determine whether patients can be effectively randomised into a study with the proposed design, and whether separation of oxygen exposure between study groups can be achieved. If careful titration of oxygen is ultimately shown to reduce brain injury after cardiac arrest, this finding will have a major impact on the management of cardiac arrest in New Zealand and internationally.
Interventions
Patients assigned to the ‘avoidance of hyperoxia’ arm will receive titrated oxygen from the time of ROSC aiming to achieve oxygen saturation of 90-94% via pulse oximeter. If pulse oximetry cannot be established or stops working in the ambulance, patients will be administered 100% oxygen until such time as working pulse oximetry can be established to avoid any risk of severe undetected hypoxaemia. Titrated oxygen therapy via adjustments in ventilator inspired oxygen concentration will then be m
Patients assigned to the ‘avoidance of hyperoxia’ arm will receive titrated oxygen from the time of ROSC aiming to achieve oxygen saturation of 90-94% via pulse oximeter. If pulse oximetry cannot be established or stops working in the ambulance, patients will be administered 100% oxygen until such time as working pulse oximetry can be established to avoid any risk of severe undetected hypoxaemia. Titrated oxygen therapy via adjustments in ventilator inspired oxygen concentration will then be maintained throughout the period of treatment in the emergency department and ICU up until extubation or 72 hours post ROSC (whichever is sooner). Once patients have arrived in the hospital, oxygen can be titrated according to blood gases if pulse oximetry is not reading reliably. In these circumstances, the oxygen concentration should be titrated to the oxygen saturation on the blood gases rather than to the PaO2.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Return of spontaneous circulation following cardiac arrest due to a primary cardiac cause with an initial rhythm of VF or VT 2. Aged 16-90 years 3. Ventilated via endotracheal tube or laryngeal mask airway.
Exclusion criteria
1. Obvious pregnancy 2. Living in supported care or a nursing home 3. Terminal disease 4. More than 20 minutes have elapsed since return of spontaneous circulation
Outcome results
None listed