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

NCT04130984 | Unknown

• 1 other identifier: z2jzk20191015
• Study Type: interventional
• Target: 2,356
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Background:
2. 2.Materials and methods:
3. 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

Keywords

Out-of-Hospital Cardiac Arrest; Intraosseous; Intravenous; Resuscitation

Outcome Measures

Primary Outcomes (1)

• return of spontaneous circulation (ROSC)

  ROSC can be identified with the following three conditions: 1. arterial pulse can be reached; 2. effective ECG rhythm; 3. systolic blood pressure \> 60 mmHg (1 mm Hg = 0.133 kPa);.

  within 24 hours

Secondary Outcomes (5)

• first attempt success

  within 24 hours

• overall success

  within 24 hours

• initial access interval

  within 24 hours

• initial epinephrine administration interval

  within 24 hours

• sustained ROSC

  24 hours

Other Outcomes (5)

• survival to discharge

  a week

• survival to discharge without severe neurological impairment

  a week

• 1-month survival without severe neurological impairment

  1 month

Study Arms (2)

Group IO

EXPERIMENTAL

Intraosseous assess will be established in group IO, using EZ-IO for drug or fuild resuscitation. Proximal tibia is the insertion site,locating at 1 cm medial tibial tuberosity. IO access should be retained for less than 1 day, and venous access should be established as soon as possible after winning rescue time to continue treatment. Other treatment measures refer to 2015 AHA guidelines.

Device: EZ-IO

Group IV

NO INTERVENTION

Intravenous access will be established in group IV, choosing any available peripheral venous for the administration of drugs or fluids.The antecubital vein is the preferred choice. If failed, the next catheterization plan will be determined by the physician in charge of the scene.Other treatment measures also refer to 2015 AHA guidelines.

Interventions

EZ-IO DEVICE

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.

Also known as: IO device

Group IO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Out of hospital cardiac arrest patients with 18 years or more

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The First Affiliated Hospital of Soochow University: collaborator
• The Sixth Affiliated Hospital of Wenzhou Medical University: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Shanghai 10th People's Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• West China Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Ningbo Medical Center Lihuili Hospital: collaborator
• Henan Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Shandong Provincial Hospital: collaborator
• The Third Affiliated Hospital of Wenzhou Medical University: collaborator
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (16)

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  PMID: 26472995 BACKGROUND

• Petitpas F, Guenezan J, Vendeuvre T, Scepi M, Oriot D, Mimoz O. Use of intra-osseous access in adults: a systematic review. Crit Care. 2016 Apr 14;20:102. doi: 10.1186/s13054-016-1277-6.

  PMID: 27075364 BACKGROUND

• Ong MEH, Chan YH, Oh JJ, Ngo AS. An observational, prospective study comparing tibial and humeral intraosseous access using the EZ-IO. Am J Emerg Med. 2009 Jan;27(1):8-15. doi: 10.1016/j.ajem.2008.01.025.

  PMID: 19041528 BACKGROUND

• Kurowski A, Timler D, Evrin T, Szarpak L. Comparison of 3 different intraosseous access devices for adult during resuscitation. Randomized crossover manikin study. Am J Emerg Med. 2014 Dec;32(12):1490-3. doi: 10.1016/j.ajem.2014.09.007. Epub 2014 Sep 18.

  PMID: 25440232 BACKGROUND

• Reades R, Studnek JR, Vandeventer S, Garrett J. Intraosseous versus intravenous vascular access during out-of-hospital cardiac arrest: a randomized controlled trial. Ann Emerg Med. 2011 Dec;58(6):509-16. doi: 10.1016/j.annemergmed.2011.07.020.

  PMID: 21856044 BACKGROUND

• Soar J, Nolan JP, Bottiger BW, Perkins GD, Lott C, Carli P, Pellis T, Sandroni C, Skrifvars MB, Smith GB, Sunde K, Deakin CD; Adult advanced life support section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 3. Adult advanced life support. Resuscitation. 2015 Oct;95:100-47. doi: 10.1016/j.resuscitation.2015.07.016. No abstract available.

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  PMID: 20176434 BACKGROUND

• Zuercher M, Kern KB, Indik JH, Loedl M, Hilwig RW, Ummenhofer W, Berg RA, Ewy GA. Epinephrine improves 24-hour survival in a swine model of prolonged ventricular fibrillation demonstrating that early intraosseous is superior to delayed intravenous administration. Anesth Analg. 2011 Apr;112(4):884-90. doi: 10.1213/ANE.0b013e31820dc9ec. Epub 2011 Mar 8.

  PMID: 21385987 BACKGROUND

• Feinstein BA, Stubbs BA, Rea T, Kudenchuk PJ. Intraosseous compared to intravenous drug resuscitation in out-of-hospital cardiac arrest. Resuscitation. 2017 Aug;117:91-96. doi: 10.1016/j.resuscitation.2017.06.014. Epub 2017 Jun 16.

  PMID: 28629995 BACKGROUND

• Kawano T, Grunau B, Scheuermeyer FX, Gibo K, Fordyce CB, Lin S, Stenstrom R, Schlamp R, Jenneson S, Christenson J. Intraosseous Vascular Access Is Associated With Lower Survival and Neurologic Recovery Among Patients With Out-of-Hospital Cardiac Arrest. Ann Emerg Med. 2018 May;71(5):588-596. doi: 10.1016/j.annemergmed.2017.11.015. Epub 2018 Jan 6.

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• Lewis FR Jr. Prehospital intravenous fluid therapy: physiologic computer modelling. J Trauma. 1986 Sep;26(9):804-11. doi: 10.1097/00005373-198609000-00005.

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  PMID: 16507183 BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Study Officials

• Mao Zhang

  Second Affiliated Hospital, Zhejiang Universitiy School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mao Zhang

CONTACT

86-571-87784654; z2jzk@zju.edu.cn

Libing Jiang

CONTACT

13738062354@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: June 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: May 11, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)