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

Study 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.

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

Conditions
-----------------
Airway Control

Participation Criteria
=================
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intraosseous (IO) drug delivery<br>patients in whom intraosseous (IO) vascular access has been established for rapid sequence intubation drug delivery. | |
| Peripheral intravenous (IV) drug delivery<br>patients in whom peripheral intravenous (IV) vascular access has been established for rapid sequence intubation drug delivery. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | failure rate of endotracheal intubation and requirement for alternative airway management. | 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 |