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

Terminated

• Conditions: Airway Control

• Registration Number: NCT01486407
• Lead Sponsor: Vidacare Corporation

Brief Summary

This study will evaluate using intraosseous vascular access and intravenous vascular access to give patients the necessary medications to perform rapid sequence intubation, for patients with airway difficulties. The investigators think the device operator will find the intraosseous and intravenous routes equal for drug delivery.

Detailed Description

This observational study will evaluate the intubating conditions of patients receiving rapid sequence intubation when receiving paralytic drug delivery via intravenous or intraosseous vascular access from the perspective of the medical professional performing rapid sequence intubation. The investigators believe that medical professionals will find equal intubating conditions for intravenous and intraosseous drug delivery.

Study Timeline

• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-06
• Study Start: 2012-02
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Requires rapid sequence intubation
• Succinylcholine is chosen paralytic agent
• IV or IO access has been established for rapid sequence intubation
• For IV access patients, their rapid sequence intubation case is the next occurring IV rapid sequence intubation case following an enrolled IO RSI case.

Exclusion Criteria

• Vascular access other than IV or IO has been established

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from first drug delivery to operator-perceived sufficient relaxation to perform endotracheal tube placement	during rapid sequence intubation procedure, average expected time frame 30 minutes
Intubation difficulty using the intubation difficulty scale	during rapid sequence intubation procedure, average expected time frame 30 minutes
Operator satisfaction with intubating conditions using visual analog scale	during rapid sequence intubation procedure, average expected time frame 30 minutes
Failure rate of endotracheal intubation and requirement for alternative airway management methods	during rapid sequence intubation procedure, average time frame 30 minutes

Secondary Outcome Measures

Name	Time	Method
Incidence of short-term catheter related complications for each technique	during emergency department stay, average time frame 24 hours

Trial Locations

Locations (2)

Christus Spohn Hospital Corpus Christi; 🇺🇸 Corpus Christi, Texas, United States

Texas Tech University Health Science Center El Paso; 🇺🇸 El Paso, Texas, United States