Observational Study of Rapid Sequence Intubation (RSI) Drug Delivery Using Intraosseous (IO) and Intravenous (IV) Access.

An Observational Study of Intubating Conditions Comparing Intraosseous Vascular Access With Peripheral Intravenous Access for Drug Delivery in Rapid Sequence Intubation

This study will evaluate using intraosseous vascular access and intravenous vascular access to give patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties. The investigators think the device operator will find the intraosseous and intravenous routes equal for drug delivery.

Study Overview

• Status: Terminated
• Conditions: Airway Control

Detailed Description

This observational study will evaluate the intubating conditions of patients receiving rapid sequence intubation when receiving paralytic drug delivery via intravenous or intraosseous vascular access from the perspective of the medical professional performing rapid sequence intubation. The investigators believe that medical professionals will find equal intubating conditions for intravenous and intraosseous drug delivery.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Corpus Christi, Texas, United States, 78405
      • Christus Spohn Hospital Corpus Christi
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Science Center El Paso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in the emergency department with airway difficulties requiring rapid sequence intubation.

Description

Inclusion Criteria:

• Requires rapid sequence intubation
• Succinylcholine is chosen paralytic agent
• IV or IO access has been established for rapid sequence intubation
• For IV access patients, their rapid sequence intubation case is the next occurring IV rapid sequence intubation case following an enrolled IO RSI case.

Exclusion Criteria:

• Vascular access other than IV or IO has been established

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Intravenous (IV) drug delivery; patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery.
Intraosseous (IO) drug delivery; Patients on whom intraosseous vascular access has been established for rapid sequence intubation drug delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time from first drug delivery to operator-perceived sufficient relaxation to perform endotracheal tube placement	during rapid sequence intubation procedure, average expected time frame 30 minutes
Intubation difficulty using the intubation difficulty scale	during rapid sequence intubation procedure, average expected time frame 30 minutes
Operator satisfaction with intubating conditions using visual analog scale	during rapid sequence intubation procedure, average expected time frame 30 minutes
Failure rate of endotracheal intubation and requirement for alternative airway management methods	during rapid sequence intubation procedure, average time frame 30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of short-term catheter related complications for each technique	during emergency department stay, average time frame 24 hours

Collaborators and Investigators

• Sponsor: Vidacare Corporation
• Investigators: Principal Investigator: Stephen W Borron, MD, Texas Tech University Health Science Center

Publications and helpful links

General Publications

• Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. doi: 10.1097/CCM.0b013e31819323c6. Erratum In: Crit Care Med. 2009 Apr;37(4):1536. Skache, Sara [corrected to Kache, Saraswati]; Irazusta, Jose [corrected to Irazuzta, Jose].
• Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
• Deakin CD, Nolan JP, Sunde K, Koster RW. European Resuscitation Council Guidelines for Resuscitation 2010 Section 3. Electrical therapies: automated external defibrillators, defibrillation, cardioversion and pacing. Resuscitation. 2010 Oct;81(10):1293-304. doi: 10.1016/j.resuscitation.2010.08.008. No abstract available.
• 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.
• Leidel BA, Kirchhoff C, Bogner V, Braunstein V, Biberthaler P, Kanz KG. Comparison of intraosseous versus central venous vascular access in adults under resuscitation in the emergency department with inaccessible peripheral veins. Resuscitation. 2012 Jan;83(1):40-5. doi: 10.1016/j.resuscitation.2011.08.017. Epub 2011 Sep 3.
• Kleinman ME, de Caen AR, Chameides L, Atkins DL, Berg RA, Berg MD, Bhanji F, Biarent D, Bingham R, Coovadia AH, Hazinski MF, Hickey RW, Nadkarni VM, Reis AG, Rodriguez-Nunez A, Tibballs J, Zaritsky AL, Zideman D; Pediatric Basic and Advanced Life Support Chapter Collaborators. Pediatric basic and advanced life support: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Pediatrics. 2010 Nov;126(5):e1261-318. doi: 10.1542/peds.2010-2972A. Epub 2010 Oct 18. No abstract available.
• Von Hoff DD, Kuhn JG, Burris HA 3rd, Miller LJ. Does intraosseous equal intravenous? A pharmacokinetic study. Am J Emerg Med. 2008 Jan;26(1):31-8. doi: 10.1016/j.ajem.2007.03.024.
• Orlowski JP, Porembka DT, Gallagher JM, Lockrem JD, VanLente F. Comparison study of intraosseous, central intravenous, and peripheral intravenous infusions of emergency drugs. Am J Dis Child. 1990 Jan;144(1):112-7. doi: 10.1001/archpedi.1990.02150250124049.
• Laurin EG, Sakles JC, Panacek EA, Rantapaa AA, Redd J. A comparison of succinylcholine and rocuronium for rapid-sequence intubation of emergency department patients. Acad Emerg Med. 2000 Dec;7(12):1362-9. doi: 10.1111/j.1553-2712.2000.tb00493.x.
• Perry JJ, Lee JS, Sillberg VA, Wells GA. Rocuronium versus succinylcholine for rapid sequence induction intubation. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD002788. doi: 10.1002/14651858.CD002788.pub2.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: December 2, 2011
• First Submitted That Met QC Criteria: December 5, 2011
• First Posted (Estimate): December 6, 2011

Study Record Updates

• Last Update Posted (Estimate): February 1, 2013
• Last Update Submitted That Met QC Criteria: January 31, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Airway management
• Other Study ID Numbers: 2011-13 (ICIRC)