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

September 4, 2017 updated by: Professor Stephen Bernard, Monash University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 90% 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 of 90-94%.

Patients allocated to oxygen >10L minute ("standard care") will continue on this therapy to hospital.

In the 2L/min oxygen group, the oxygen flow will be changed immediately back to >10L/min if:

  • The oxygen saturation falls to <90% at any time, or
  • Recurrent cardiac arrest occurs, or
  • The pulse oximeter trace fails Following any of these events, this high-flow oxygen will continue to hospital. If a patient is extubated or has a SGA removed post randomisation because of improving conscious state, then standard care will be used (i.e. face mask with oxygen ≥10L/min).

For patients with ROSC in whom intubation is planned, ventilation with high-flow oxygen will continue during the intubation process and randomisation will be delayed until 2 minutes after the ETT is confirmed as correctly placed using ETCO2 and the pulse oximeter trace reads ≥95%.

At ED handover, the patient will receive oxygen therapy as determined by the treating emergency medicine physician.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia
        • SA Ambulance Service
    • Victoria
      • Melbourne, Victoria, Australia
        • Ambulance Victoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (age ≥18 years)
  • Out-of-hospital cardiac arrest of presumed cardiac cause
  • Initial cardiac rhythm ventricular fibrillation/ ventricular tachycardia ("shockable")
  • Unconscious (Glasgow Coma Scale <9)
  • In cardiac arrest on ambulance arrival
  • Sustained return of spontaneous circulation (>2 minutes)
  • Pulse oximeter trace with oxygen saturation measured at ≥95% on bag/ reservoir with oxygen set at ≥10L/min
  • Patient is spontaneous breathing or ventilated using bag/valve/oxygen reservoir via endotracheal tube or SGA (i.e. laryngeal mask airway)

Exclusion Criteria:

  • Female who is known or suspected to be pregnant
  • Dependant on others for activities of daily living (i.e. facilitated care or nursing home residents)
  • "Not for Resuscitation" order
  • EMS witnessed arrests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxygen reduction
post-ROSC oxygen reduced to 2L per minute then delivered to maintain oxygen saturation 90-94% to hospital
Drug: Oxygen
oxygen delivery by ETT/ SGA connected to bag/valve/oxygen reservoir
Active Comparator: Standard Care
post-ROSC oxygen maintained ≥10L per minute to hospital
Drug: Oxygen
oxygen delivery by ETT/ SGA connected to bag/valve/oxygen reservoir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxygen saturation ≥90%
Time Frame: baseline
Oxygen saturation measured on arrival at hospital by paramedics
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash University

Collaborators

Curtin University
Flinders University
Ambulance Victoria
SA Ambulance Service

Investigators

  • Principal Investigator: Stephen Bernard, MD, Monash University / Alfred Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Actual)

September 7, 2017

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CF14/2953-2014001634

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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