Clinical trial NCT01634867: Observational Study of Rapid Sequence Intubation (RSI) Drug Delivery Using Intraosseous (IO) and Intravenous (IV) Access in Pediatric Patients
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Airway Control
Lead sponsor: Vidacare Corporation
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients in the emergency department with airway difficulties requiring rapid sequence intubation.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.
timeFrame: during rapid sequence intubation procedure, average expected time frame 30 minutes
measure: Time from vascular access to intubation first attempt, as indicated by the first attempt to visualize the larynx with the laryngoscope.
timeFrame: during rapid sequence intubation procedure, average expected time frame 30 minutes
measure: time from vascular access to successful intubation
timeFrame: during rapid sequence intubation procedure, average expected time frame 30 minutes
measure: number of attempts necessary for successful intubation
timeFrame: during rapid sequence intubation procedure, average expected time frame 30 minutes
Secondary outcomes:
measure: Intubation difficulty
timeFrame: during rapid sequence intubation procedure, average time frame 30 minutes
measure: operator satisfaction with intubating conditions
timeFrame: during rapid sequence intubation procedure, average time frame 30 minutes
measure: failure rate of endotracheal intubation
timeFrame: during rapid sequence intubation procedure, average time frame 30 minutes
measure: Time from presentation of patient to vascular access established
timeFrame: during rapid sequence intubation procedure, average time frame 30 minutes
measure: Determine the incidence of short term catheter related complications for each technique
timeFrame: during emergency department stay, average time frame 24 hours
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Omaha Children's Hospital and Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Edward Truemper, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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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. doi: 10.1001/archpedi.1990.02150250124049.
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