Rapid Sequence Intubation Drug Delivery Using Intraosseous and IV Access in Pediatric Patients Observational Study

NCT01634867 | Withdrawn

• 1 other identifier: 2012-03
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway Control

Outcome Measures

Primary Outcomes (4)

• Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.

  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.

  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

  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

  number of attempts necessary for successful intubation

  during rapid sequence intubation procedure, average expected time frame 30 minutes

Secondary Outcomes (5)

• Intubation difficulty

  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

  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

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Vidacare Corporation: lead

Study Sites (1)

Omaha Children's Hospital and Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (10)

• 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

• 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.

  PMID: 9416711 BACKGROUND

• 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.

  PMID: 21893125 BACKGROUND

• 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.

  PMID: 20956049 BACKGROUND

• 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.

  PMID: 20956258 BACKGROUND

• 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.

  PMID: 19325359 BACKGROUND

• 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.

  PMID: 18082778 BACKGROUND

• 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.

  PMID: 1688484 BACKGROUND

• 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.

  PMID: 11099426 BACKGROUND

• 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.

  PMID: 18425883 BACKGROUND

Study Officials

• Edward Truemper, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 6, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 2, 2026

Record last verified: 2014-12

Locations

US (1)