Status:
UNKNOWN
Intraosseous Versus Intravenous Vascular Access During Resuscitation Following Out-of-Hospital Cardiac Arrest
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
The First Affiliated Hospital of Soochow University
The Sixth Affiliated Hospital of Wenzhou Medical University
Conditions:
Out-of-Hospital Cardiac Arrest
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
1. Background: Intraosseous (IO) access is a new, fast, safe and efficient route of rescue of critically ill patients. Studies found drug pharmacokinetics and pharmacodynamics of IO are similar to...
Detailed Description
1. Background: Successful vascular access is critical for the treatment of acute and critically ill patients, especially those with cardiac arrest. For cardiac arrest patients, besides high-qualit...
Eligibility Criteria
Inclusion
- Out of hospital cardiac arrest patients with 18 years or more
Exclusion
- Traumatic cardiopulmonary arrest with an indication of withholding of resuscitation, including:
- trauma victims with injuries that are obviously incompatible with life, such as decapitation or hemicorporectomy;
- victims of either blunt or penetrating trauma when there is evidence of prolonged cardiac arrest, including rigor mortis or dependent lividity;
- blunt trauma patient who, on the arrival of emergency medical services (EMS) personnel, is found to be apneic, pulseless, and without organized electrocardiographic activity;
- penetrating trauma patients who, on the arrival of EMS personnel, is found to be pulseless and apneic and there are no other signs of life, including spontaneous movement, electrocardiographic activity, and pupillary response;
- Vascular access has been established before admission;
- Return of spontaneous circulation before first attempt to establish vascular access;
- Quit resuscitation;
- Patients with contraindications of intraosseous access;
- infection of insertion site, such as skin and soft tissue infections, osteomyelitis;
- integrity damage of the target bone, such as fractures, artificial limbs, etc;
- blood supply or return of the target bone is significantly affected, e.g. arteriovenous rupture;
- burns of insertion site;
- intraosseous attempt in same insertion site within 24 h;
- compartment syndrome exists in same insertion site;
- unclear anatomical structures of insertion site, such as obesity, malformations;
- patients with severe bone diseases, such as imperfect osteogenesis, osteoporosis;
- patients with right to left cardiac shunt (e.g. Tetralogy of Fallot, pulmonary atresia, etc).
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
2356 Patients enrolled
Trial Details
Trial ID
NCT04130984
Start Date
June 1 2020
End Date
June 1 2023
Last Update
May 11 2020
Active Locations (1)
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1
Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009