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WithdrawnNCT01634867Updated Apr 2, 2026

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

An observational study in Airway Control, sponsored by Vidacare Corporation. Withdrawn at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Vidacare Corporation · Observational

Why this study was withdrawn
No subject enrollment.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
0
Sex
All
01

Study 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.

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Conditions studied

  • Airway Control
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In context

Lead sponsor

Vidacare Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. time from vascular access to successful intubation

    time from vascular access to successful intubation

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

  4. number of attempts necessary for successful intubation

    number of attempts necessary for successful intubation

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

Secondary outcomes

  1. 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.

    Time frame: during rapid sequence intubation procedure, average time frame 30 minutes

  2. operator satisfaction with intubating conditions

    operator satisfaction with intubating conditions

    Time frame: during rapid sequence intubation procedure, average time frame 30 minutes

  3. failure rate of endotracheal intubation

    failure rate of endotracheal intubation and requirement for alternative airway management.

    Time frame: during rapid sequence intubation procedure, average time frame 30 minutes

  4. Time from presentation of patient to vascular access established

    Time from presentation of patient to vascular access established

    Time frame: during rapid sequence intubation procedure, average time frame 30 minutes

  5. Determine the incidence of short term catheter related complications for each technique

    Determine the incidence of short term catheter related complications for each technique

    Time frame: during emergency department stay, average time frame 24 hours

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Study locations

1 site
  • Omaha Children's Hospital and Medical Center
    Omaha, Nebraska 68198, United States
08

References and documents

Publications

  • 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. PubMed 21856044 ↗
  • 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. PubMed 9416711 ↗
  • 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. PubMed 21893125 ↗
  • 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. PubMed 20956049 ↗
  • 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. PubMed 20956258 ↗
  • 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. PubMed 19325359 ↗
  • 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. PubMed 18082778 ↗
  • 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. PubMed 1688484 ↗
  • 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. PubMed 11099426 ↗
  • 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. PubMed 18425883 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01634867
Lead sponsor
Vidacare Corporation
Responsible party
Sponsor
First posted
Jul 6, 2012
Start date
Sep 2012
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Apr 2, 2026

Study contacts

Edward Truemper, MD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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