Observational Study of Rapid Sequence Intubation Drug Delivery Using Intraosseous and Intravenous Access.

NCT01486407 | Terminated Results

• 1 other identifier: 2011-13
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Airway Control

Keywords

Airway management

Outcome Measures

Primary Outcomes (4)

• Time From First Drug Delivery to Operator-perceived Sufficient Relaxation to Perform Endotracheal Tube Placement

  Time measured in seconds from first drug delivery to the time of operator-perceived sufficient relaxation to perform endotracheal tube placement

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

• Intubation Difficulty Scale

  Intubation Difficulty Scale (IDS) provides a numerical Total score describing the difficulty of the intubation procedure based upon the summation of the following individual sub-scores: number of attempts (each additional attempt adds (+)1 point, minimum score=0, no maximum), number of operators (each additional +1 point, minimum score=0, no maximum), use of alternative techniques (each alternative technique +1 point, minimum score=0, no maximum), cormack grade for first oral attempt (measures the quality of the view of the larynx using grades 1 - 4 where higher number means poorer visibility; successful blind intubation=0. minimum score=0, maximum=4), lifting force required (normal=0 or increased=1), laryngeal pressure (not applied=0 or applied=1), vocal cord mobility (abduction=0 or adduction=1). Total IDS minimum score=0, no maximum score. Score 0=Easy; Score 1 - 5 =slight difficulty; Score \>5 =moderate to major difficulty Score infinite =Failed/Impossible intubation

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

• Operator Satisfaction With Intubating Conditions Using Visual Analog Scale

  Operator reported level of satisfaction with intubating conditions regarding adequacy of sedation and adequacy of muscular relaxation. This is reported using a 100 mm visual analog scale from 0 - 100 where higher numbers indicate greater satisfaction.

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

• Failure Rate of Endotracheal Intubation and Requirement for Alternative Airway Management Methods

  Failure rate of endotracheal intubation and requirement for alternative airway management methods

  during rapid sequence intubation procedure, average time frame 30 minutes

Secondary Outcomes (1)

• Incidence of Short-term Catheter Related Complications for Each Technique

  during emergency department stay, average time frame 24 hours

Study Arms (2)

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.

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:

• Requires rapid sequence intubation
• Succinylcholine is chosen paralytic agent
• Intravenous (IV) or Intraosseous (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 Rapid Sequence Intubation (RSI) case.

You may not qualify if:

• Vascular access other than IV or IO has been established

Sponsors & Collaborators

• Vidacare Corporation: lead

Study Sites (2)

Christus Spohn Hospital Corpus Christi

Corpus Christi, Texas, 78405, United States

Location

Texas Tech University Health Science Center El Paso

El Paso, Texas, 79905, 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, 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.

  PMID: 20956050 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. 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.

  PMID: 20956433 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

Results Point of Contact

• Title: Tatiana Puga
• Organization: Teleflex

tatiana.puga@teleflex.com

Study Officials

• Stephen W Borron, MD

  Texas Tech University Health Science Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 6, 2011
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2025-12

Locations

US (2)