rEduction of oXygen After Cardiac arresT: a Pilot Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ventilation Monitoring in OHCA

NCT04988906

Out-Of-Hospital Cardiac Arrest

COMPLETED NA

Automatic Ventilation in Prehospital Resuscitation on OHCA

NCT06067204

Out-Of-Hospital Cardiac Arrest

RECRUITING NA

Blood Pressure and OXygenation Targets After OHCA

NCT03141099

Out-of-Hospital Cardiac Arrest Blood Pressure Hemodynamic Instability

COMPLETED NA

Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation

NCT02698917

Out-of-Hospital Cardiac Arrest

COMPLETED NA

Cardiac Catheterization in Cardiac Arrest

NCT02587494

Out of Hospital Cardiac Arrest

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oxygen reduction

post-ROSC oxygen reduced to 2L per minute then delivered to maintain oxygen saturation 90-94% to hospital

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

oxygen delivery by ETT/ SGA connected to bag/valve/oxygen reservoir

Standard Care

post-ROSC oxygen maintained ≥10L per minute to hospital

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type DRUG

oxygen delivery by ETT/ SGA connected to bag/valve/oxygen reservoir

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxygen

oxygen delivery by ETT/ SGA connected to bag/valve/oxygen reservoir

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No