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

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ClinicalTrials.gov Identifier: NCT01634867
Recruitment Status : Withdrawn (No subject enrollment.)
First Posted : July 6, 2012
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Airway Control

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Study Start Date : September 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Group/Cohort
Intraosseous (IO) drug delivery
patients in whom intraosseous (IO) vascular access has been established for rapid sequence intubation drug delivery.
Peripheral intravenous (IV) drug delivery
patients in whom peripheral intravenous (IV) vascular access has been established for rapid sequence intubation drug delivery.



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. time from vascular access to successful intubation [ Time Frame: during rapid sequence intubation procedure, average expected time frame 30 minutes ]
  4. number of attempts necessary for successful intubation [ Time Frame: during rapid sequence intubation procedure, average expected time frame 30 minutes ]

Secondary Outcome Measures :
  1. Intubation difficulty [ Time Frame: 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.

  2. operator satisfaction with intubating conditions [ Time Frame: during rapid sequence intubation procedure, average time frame 30 minutes ]
  3. failure rate of endotracheal intubation [ Time Frame: during rapid sequence intubation procedure, average time frame 30 minutes ]
    failure rate of endotracheal intubation and requirement for alternative airway management.

  4. Time from presentation of patient to vascular access established [ Time Frame: during rapid sequence intubation procedure, average time frame 30 minutes ]
  5. Determine the incidence of short term catheter related complications for each technique [ Time Frame: during emergency department stay, average time frame 24 hours ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01634867


Locations
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United States, Nebraska
Omaha Children's Hospital and Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
Vidacare Corporation
Investigators
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Principal Investigator: Edward Truemper, MD University of Nebraska
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. doi: 10.1097/CCM.0b013e31819323c6. Erratum in: Crit Care Med. 2009 Apr;37(4):1536. Skache, Sara [corrected to Kache, Saraswati]; Irazusta, Jose [corrected to Irazuzta, Jose].

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Responsible Party: Vidacare Corporation
ClinicalTrials.gov Identifier: NCT01634867    
Other Study ID Numbers: 2012-03
First Posted: July 6, 2012    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014