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Clinical Trials/NCT01634867
NCT01634867
Withdrawn
Not Applicable

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

Vidacare Corporation1 site in 1 countrySeptember 2012
ConditionsAirway Control

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Airway Control
Sponsor
Vidacare Corporation
Locations
1
Primary Endpoint
Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.
Status
Withdrawn
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
August 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Vidacare Corporation
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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

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

time from vascular access to successful intubation

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

number of attempts necessary for successful intubation

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

Secondary Outcomes

  • Intubation difficulty(during rapid sequence intubation procedure, average time frame 30 minutes)
  • operator satisfaction with intubating conditions(during rapid sequence intubation procedure, average time frame 30 minutes)
  • failure rate of endotracheal intubation(during rapid sequence intubation procedure, average time frame 30 minutes)
  • Time from presentation of patient to vascular access established(during rapid sequence intubation procedure, average time frame 30 minutes)
  • Determine the incidence of short term catheter related complications for each technique(during emergency department stay, average time frame 24 hours)

Study Sites (1)

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