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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01634867
Enrollment
0
Registered
2012-07-06
Start date
2012-09-01
Completion date
2014-08-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Control

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.

Interventions

None listed

Sponsors

Vidacare Corporation
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 minutesTime from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.
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 minutesTime 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 successful intubationduring rapid sequence intubation procedure, average expected time frame 30 minutestime from vascular access to successful intubation
number of attempts necessary for successful intubationduring rapid sequence intubation procedure, average expected time frame 30 minutesnumber of attempts necessary for successful intubation

Secondary

MeasureTime frameDescription
Intubation difficultyduring rapid sequence intubation procedure, average time frame 30 minutesThe 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.
operator satisfaction with intubating conditionsduring rapid sequence intubation procedure, average time frame 30 minutesoperator satisfaction with intubating conditions
failure rate of endotracheal intubationduring rapid sequence intubation procedure, average time frame 30 minutesfailure rate of endotracheal intubation and requirement for alternative airway management.
Time from presentation of patient to vascular access establishedduring rapid sequence intubation procedure, average time frame 30 minutesTime from presentation of patient to vascular access established
Determine the incidence of short term catheter related complications for each techniqueduring emergency department stay, average time frame 24 hoursDetermine the incidence of short term catheter related complications for each technique

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREdward Truemper, MD

University of Nebraska

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026