Observational Study of Rapid Sequence Intubation (RSI) Drug Delivery Using Intraosseous (IO) and Intravenous (IV) Access in Pediatric Patients

Withdrawn

• Conditions: Airway Control

• Registration Number: NCT01634867
• Lead Sponsor: Vidacare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-06
• Study Start: 2012-09
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-19
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 minutes
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 minutes
time from vascular access to successful intubation	during rapid sequence intubation procedure, average expected time frame 30 minutes
number of attempts necessary for successful intubation	during rapid sequence intubation procedure, average expected time frame 30 minutes

Secondary Outcome Measures

Name	Time	Method
Intubation difficulty	during rapid sequence intubation procedure, average time frame 30 minutes	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.
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	failure rate of endotracheal intubation and requirement for alternative airway management.
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

Trial Locations

Locations (1)

Omaha Children's Hospital and Medical Center; 🇺🇸 Omaha, Nebraska, United States