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

A Pilot Study of Intubating Conditions Comparing Intraosseous Vascular Access With Peripheral Intravenous Access for Drug Delivery in Rapid Sequence Intubation Using Rocuronium as the Paralytic Agent

This study will evaluate using intraosseous vascular access and intravenous vascular access to give pediatric patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties.

Study Overview

• Status: Withdrawn
• Conditions: Airway Control

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Omaha Children's Hospital and Medical Center

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:

• subjects requiring rapid sequence intubation for whom rocuronium is chosen as the paralytic agent.
• the operator chooses to place a peripheral intravenous or powered intraosseous catheter to permit rapid sequence intubation.

Exclusion Criteria:

• subjects in whom vascular access for rapid sequence intubation drug administration was established prior to arrival to the emergency department.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Intraosseous (IO) drug delivery; patients in whom intraosseous (IO) vascular access has been established for rapid sequence intubation drug delivery.
Peripheral intravenous (IV) drug delivery; patients in whom peripheral intravenous (IV) 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 determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.	during rapid sequence intubation procedure, average expected time frame 30 minutes
Time from vascular access to intubation first attempt, as indicated by the first attempt to visualize the larynx with the laryngoscope.	during rapid sequence intubation procedure, average expected time frame 30 minutes
time from vascular access to successful intubation	during rapid sequence intubation procedure, average expected time frame 30 minutes
number of attempts necessary for successful intubation	during rapid sequence intubation procedure, average expected time frame 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation difficulty	The Intubation Difficulty Scale is a validated tool used to grade the difficulty with which a patient was intubated for airway managment during rapid sequence intubation.	during rapid sequence intubation procedure, average time frame 30 minutes
operator satisfaction with intubating conditions		during rapid sequence intubation procedure, average time frame 30 minutes
failure rate of endotracheal intubation	failure rate of endotracheal intubation and requirement for alternative airway management.	during rapid sequence intubation procedure, average time frame 30 minutes
Time from presentation of patient to vascular access established		during rapid sequence intubation procedure, average time frame 30 minutes
Determine the 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: Edward Truemper, MD, University of Nebraska

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.
• 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.
• 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.
• Deakin CD, Nolan JP, Soar J, Sunde K, Koster RW, Smith GB, Perkins GD. European Resuscitation Council Guidelines for Resuscitation 2010 Section 4. Adult advanced life support. Resuscitation. 2010 Oct;81(10):1305-52. doi: 10.1016/j.resuscitation.2010.08.017. No abstract available. Erratum In: Resuscitation. 2011 Jan;82(1):140.
• 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. Part 10: Pediatric basic and advanced life support: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S466-515. doi: 10.1161/CIRCULATIONAHA.110.971093.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 2, 2012
• First Submitted That Met QC Criteria: July 5, 2012
• First Posted (Estimate): July 6, 2012

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 19, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 2012-03