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

Airway Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01634867
• Other study ID #: 2012-03
• Status: Withdrawn
• Phase: N/A
• First received: July 2, 2012
• Last updated: December 19, 2014
• Start date: September 2012
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: Vidacare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Airway Control

Locations

Country	Name	City	State
United States	Omaha Children's Hospital and Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Vidacare Corporation

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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]. — View Citation

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. Erratum in: Resuscitation. 2011 Jan;82(1):140. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2015;10:CD002788. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	time from vascular access to successful intubation		during rapid sequence intubation procedure, average expected time frame 30 minutes	No
Primary	number of attempts necessary for successful intubation		during rapid sequence intubation procedure, average expected time frame 30 minutes	No
Secondary	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	No
Secondary	operator satisfaction with intubating conditions		during rapid sequence intubation procedure, average time frame 30 minutes	No
Secondary	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	No
Secondary	Time from presentation of patient to vascular access established		during rapid sequence intubation procedure, average time frame 30 minutes	No
Secondary	Determine the incidence of short term catheter related complications for each technique		during emergency department stay, average time frame 24 hours	No