Intraosseous Versus Intravenous Vascular Access During Resuscitation Following Out-of-Hospital Cardiac Arrest

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 IV route. Compared with IV and CVC, IO is time-consuming, easy to grasp, and has high operation success rate. Guidelines recommend IO when the establishment of vascular access is difficult or impossible.

Recent animal studies suggest that IO access have better ventricular fibrillation termination rates, ROSC rates and survival compared with IV route. However, recent retrospective clinical studies found that IO versus IV treatment was associated with a lower likelihood of ROSC and hospitalization. How routes of vascular access influence clinical outcomes after OHCA merits multicenter randomized controlled trial. We suppose IO versus IV treatment is associated with a higher likelihood of ROSC and hospital and discharge survival.
2. Materials and methods:

Study design This study is a prospective, open, two-arm, multicenter randomized controlled trial. The study will be conducted by 22 medical centers or affiliated hospitals in China. We will enroll nearly 2356 OHCA patients by the eligibility and exclusion criteria during January 2020 to December 2022. All of the patients will be randomized to one of 2 routes of vascular access: tibial intraosseous or peripheral intravenous. Other treatment measures of two groups refer to 2015 AHA Advanced Cardiovascular Life Support guidelines.

Statistical analysis Intention-to-treat analysis (ITT) and per-protocol set (PPS) sensitivity analysis will be conducted in our study. Categorical variables are presented as counts and percentages, and differences are analyzed using the χ2 test. Continuous variables are presented as means with standard deviations or median (interquartile range \[IQR\]), and analysis is done by the Student t test or the Mann-Whitney U test according to normal or non-normal distributions.
3. Sample Size Calculation Set the following assumptions: alpha 0.025, beta 80%, clinically significant difference of 5% and 25% ROSC rate for both arms. Assuming the sample has an equal number of subjects in each arm, the study need to include at least 1178 subjects per arm to reach statistical significance.

Conditions

• Out-of-Hospital Cardiac Arrest

Interventions

DEVICE

EZ-IO

The insertion site locates at 1 cm medial tibial tuberosity. EZ-IO (U.S. Teleflex® Corporation) will be used with an adult 15G needle. Pull out the needle when having a sense of frustration, withdraw the bone marrow with the syringe, bolus 20 mL of normal saline to open intramedullary path and begin drug resuscitation at the same time. The retention time of IO route should be less than 24 h, and venous access should be established after winning rescue time as soon as possible to continue treatment.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• The Sixth Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Shanghai 10th People's Hospital

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• Henan Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• The Third Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Mao Zhang · Second Affiliated Hospital, Zhejiang Universitiy School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-30

Primary Completion

2022-12-31

Completion

2023-06-30

Countries

• China

Study Locations