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

This study has been terminated.
(For poor enrollment)
Sponsor:
Information provided by (Responsible Party):
Vidacare Corporation
ClinicalTrials.gov Identifier:
NCT01486407
First received: December 2, 2011
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition
Airway Control

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: An Observational Study of Intubating Conditions Comparing Intraosseous Vascular Access With Peripheral Intravenous Access for Drug Delivery in Rapid Sequence Intubation

Further study details as provided by Vidacare Corporation:

Primary Outcome Measures:
  • Time from first drug delivery to operator-perceived sufficient relaxation to perform endotracheal tube placement [ Time Frame: during rapid sequence intubation procedure, average expected time frame 30 minutes ] [ Designated as safety issue: No ]
  • Intubation difficulty using the intubation difficulty scale [ Time Frame: during rapid sequence intubation procedure, average expected time frame 30 minutes ] [ Designated as safety issue: No ]
  • Operator satisfaction with intubating conditions using visual analog scale [ Time Frame: during rapid sequence intubation procedure, average expected time frame 30 minutes ] [ Designated as safety issue: No ]
  • Failure rate of endotracheal intubation and requirement for alternative airway management methods [ Time Frame: during rapid sequence intubation procedure, average time frame 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of short-term catheter related complications for each technique [ Time Frame: during emergency department stay, average time frame 24 hours ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Intravenous (IV) drug delivery
patients on whom intravenous vascular access has been established for the purpose of rapid sequence intubation drug delivery.
Intraosseous (IO) drug delivery
Patients on whom intraosseous vascular access has been established for rapid sequence intubation 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in the emergency department with airway difficulties requiring rapid sequence intubation.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486407

Locations
United States, Texas
Christus Spohn Hospital Corpus Christi
Corpus Christi, Texas, United States, 78405
Texas Tech University Health Science Center El Paso
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Vidacare Corporation
Investigators
Principal Investigator: Stephen W Borron, MD Texas Tech University Health Science Center
  More Information

Publications:
Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. Erratum in: Crit Care Med. 2009 Apr;37(4):1536. Skache, Sara [corrected to Kache, Saraswati]; Irazusta, Jose [corrected to Irazuzta, Jose].

Responsible Party: Vidacare Corporation
ClinicalTrials.gov Identifier: NCT01486407     History of Changes
Other Study ID Numbers: 2011-13
Study First Received: December 2, 2011
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vidacare Corporation:
Airway management

ClinicalTrials.gov processed this record on September 18, 2014