Intraosseous vs Intravenous Access for Cardiac Arrest Treatment
NCT ID: NCT02088736
Last Updated: 2019-10-28
Study Results
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.
COMPLETED
PHASE4
1103 participants
INTERVENTIONAL
2014-06-30
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The assumption is that low vascular access rates could be due to difficulty of setting IV cannulas in the field due to certain factors like poor lighting or space constraints. Thus, by introducing a protocol including IO access for difficult IV cases, success rates for vascular access will be higher and this might lead to higher survival rates.
This will be a study comparing 'IV+IO' and 'IV alone' protocols in patients with cardiac arrest managed by Singapore Civil Defence Force (SCDF) emergency ambulance service. The trial will recruit 400 patients over 1 year. Each of the 30 SCDF ambulances will provide both 'IV+IO' and 'IV alone' treatments in 2 consecutive phases of 6-months in order to allow for all ambulance crew a chance to be trained on usage of IO. Currently, IO insertion is the accepted standard of care in Singapore General Hospital, Department of Emergency Medicine.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intraosseous Versus Intravenous Vascular Access During Cardiac Arrest
NCT01119807
Vascular Compression Assessment Using Transcutaneous Oxymetry in Patients Suspected of Having Thoracic Outlet Syndrome
NCT05702866
Single Lumen Midline Catheter vs Long Peripheral Intravenous Cather for Difficult Intravenous Access in the ED
NCT06668766
Intravascular Access in Suspected/Confirmed COVID-19 Patient
NCT04366947
Ultrasound-Guided BCV and IJV in ICU Patients
NCT07062068
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In adult and paediatric patients with Out-of-Hospital Cardiac Arrest (OHCA) in Singapore, investigators aim to evaluate the incremental benefit of introducing a resuscitation protocol including the use of intravenous (IV) access and/or intraosseous (IO) vascular access compared to protocols with only intravenous (IV) access by SCDF paramedics in the pre-hospital setting on the return of spontaneous circulation (ROSC) rates.
Secondary Objective:
* To compare the success rates of vascular access with IV access and/or IO insertion compared to that with intravenous (IV) access alone by SCDF paramedics in the pre-hospital setting.
* To compare the rates of successful 1st dose adrenaline given in the field to cardiac arrest patients in IV+IO and IV groups and whether this translates into a higher survival rate at 30 days.
* To determine the cost benefit of introducing IO access to the emergency ambulance service for OHCA.
Hypothesis:
In adult and paediatric patients with Out-of-Hospital Cardiac Arrest (OHCA) in Singapore, the hypothesis is that low vascular access rates could be due to difficulty of setting IV cannulas in the field due to certain factors like poor lighting or space constraints. Thus, by introducing a protocol including IO access for difficult IV cases, success rates for vascular access will be higher and this might lead to a higher ROSC and survival rates.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intravenous and Intraosseous
'IV + IO' Intravenous fluids or medications needed and a peripheral IV given 2 attempts or 90 seconds. If IV is unsuccessful, IO will attempt at the Primary site (proximal tibia). If IO is unsuccessful at scene, 2nd attempt can be done in the ambulance. Adrenaline will be delivered as according to protocol.
Intraosseous
Intravenous
Intravenous fluids or medications needed and a peripheral IV given 2 attempts or 90 seconds. If 1st IV is unsuccessful at scene, 2nd IV attempt can be done in the ambulance. Adrenaline will be delivered according to protocol.
Intravenous
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intraosseous
Intravenous
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Intravenous fluids or medications needed
Exclusion Criteria
* Paediatric needle (weight 3 - 39 kg)
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Singapore Civil Defence Force
OTHER
Singapore General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kenneth Boon Kiat Tan, MBBS
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Singapore Civil Defence Force
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NMRC/CNIG/1110/2013
Identifier Type: OTHER
Identifier Source: secondary_id
CIRB 2013/676/C
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.