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

Airway Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01486407
• Other study ID #: 2011-13
• Status: Terminated
• Phase: N/A
• First received: December 2, 2011
• Last updated: January 31, 2013
• Start date: February 2012
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Airway Control

Locations

Country	Name	City	State
United States	Christus Spohn Hospital Corpus Christi	Corpus Christi	Texas
United States	Texas Tech University Health Science Center El Paso	El Paso	Texas

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, 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. — 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. 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. — 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 first drug delivery to operator-perceived sufficient relaxation to perform endotracheal tube placement		during rapid sequence intubation procedure, average expected time frame 30 minutes	No
Primary	Intubation difficulty using the intubation difficulty scale		during rapid sequence intubation procedure, average expected time frame 30 minutes	No
Primary	Operator satisfaction with intubating conditions using visual analog scale		during rapid sequence intubation procedure, average expected time frame 30 minutes	No
Primary	Failure rate of endotracheal intubation and requirement for alternative airway management methods		during rapid sequence intubation procedure, average time frame 30 minutes	No
Secondary	Incidence of short-term catheter related complications for each technique		during emergency department stay, average time frame 24 hours	No