Clinical Trial: rEduction of oXygen After Cardiac arresT: a Pilot Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: rEduction of oXygen After Cardiac arresT (EXACT): a Pilot Study

Brief Summary: This Phase 2 study aims to determine the feasibility of paramedic titration of oxygen delivery in adult patients who have been resuscitated from OHCA.

Detailed Summary:

This Phase 2 study aims to test whether paramedic titration of oxygen is feasible and results in an equivalent number of patients arriving at the ED with a safe oxygen level compared with the current approach of 100% oxygen.

Hypothesis: There is no difference in the proportion of OHCA patients who arrive at the emergency department with oxygen saturation greater than or equal to 94% whether they received an inspired oxygen fraction of 100% achieved by a flow rate of 10 litres per minute compared to a titrated oxygen fraction achieved by a flow rate of 2 litres per minute.

This is a Phase 2, multi-centre, prospective, randomised study to be conducted in Melbourne and Adelaide.

During cardiac arrest, the patient will receive the current standard of care with oxygen delivery (≥10L/min) by ETT/ SGA connected to bag/valve/ oxygen reservoir.

If ROSC is achieved, all the standard post resuscitation treatments will be given as per current ambulance Clinical Practice Guidelines, except for the amount of oxygen delivered.

The initial ventilation post ROSC for two minutes will be 600mL x 10L/ minute with oxygen flow rate ≥10L/min until a satisfactory pulse oximeter trace and reading is achieved.

After the eligibility criteria are met, the patients will be randomised by the opening of an opaque envelope containing a computer generated allocation to either continued oxygen >10L/min or decreased ("titrated") oxygen 2L/min with a target oxygen saturation ≥94%.

Patients allocated to oxygen >10L minute ("standard care") will continue on this therapy t
Sponsor: Monash University

Current Primary Outcome: oxygen saturation ≥94% [ Time Frame: baseline ]

Oxygen saturation measured on arrival at hospital by paramedics


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Monash University

Dates:
Date Received: July 8, 2015
Date Started: July 2015
Date Completion: May 2017
Last Updated: March 23, 2017
Last Verified: March 2017