Observational Study of Rapid Sequence Intubation (RSI) Drug Delivery Using Intraosseous (IO) and Intravenous (IV) Access in Pediatric Patients
19. december 2014 opdateret af: Vidacare Corporation
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
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.
Studieoversigt
Status
Trukket tilbage
Betingelser
Undersøgelsestype
Observationel
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68198
- Omaha Children's Hospital and Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
patients in the emergency department with airway difficulties requiring rapid sequence intubation.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Intraosseous (IO) drug delivery
patients in whom intraosseous (IO) vascular access has been established for rapid sequence intubation drug delivery.
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Peripheral intravenous (IV) drug delivery
patients in whom peripheral intravenous (IV) vascular access has been established for rapid sequence intubation drug delivery.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.
Tidsramme: during rapid sequence intubation procedure, average expected time frame 30 minutes
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during rapid sequence intubation procedure, average expected time frame 30 minutes
|
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Time from vascular access to intubation first attempt, as indicated by the first attempt to visualize the larynx with the laryngoscope.
Tidsramme: during rapid sequence intubation procedure, average expected time frame 30 minutes
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during rapid sequence intubation procedure, average expected time frame 30 minutes
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time from vascular access to successful intubation
Tidsramme: during rapid sequence intubation procedure, average expected time frame 30 minutes
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during rapid sequence intubation procedure, average expected time frame 30 minutes
|
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number of attempts necessary for successful intubation
Tidsramme: during rapid sequence intubation procedure, average expected time frame 30 minutes
|
during rapid sequence intubation procedure, average expected time frame 30 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Intubation difficulty
Tidsramme: 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.
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during rapid sequence intubation procedure, average time frame 30 minutes
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operator satisfaction with intubating conditions
Tidsramme: during rapid sequence intubation procedure, average time frame 30 minutes
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during rapid sequence intubation procedure, average time frame 30 minutes
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failure rate of endotracheal intubation
Tidsramme: during rapid sequence intubation procedure, average time frame 30 minutes
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failure rate of endotracheal intubation and requirement for alternative airway management.
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during rapid sequence intubation procedure, average time frame 30 minutes
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Time from presentation of patient to vascular access established
Tidsramme: during rapid sequence intubation procedure, average time frame 30 minutes
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during rapid sequence intubation procedure, average time frame 30 minutes
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Determine the incidence of short term catheter related complications for each technique
Tidsramme: during emergency department stay, average time frame 24 hours
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during emergency department stay, average time frame 24 hours
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Edward Truemper, MD, University of Nebraska
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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].
- Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
- Reades R, Studnek JR, Vandeventer S, Garrett J. Intraosseous versus intravenous vascular access during out-of-hospital cardiac arrest: a randomized controlled trial. Ann Emerg Med. 2011 Dec;58(6):509-16. doi: 10.1016/j.annemergmed.2011.07.020.
- Leidel BA, Kirchhoff C, Bogner V, Braunstein V, Biberthaler P, Kanz KG. Comparison of intraosseous versus central venous vascular access in adults under resuscitation in the emergency department with inaccessible peripheral veins. Resuscitation. 2012 Jan;83(1):40-5. doi: 10.1016/j.resuscitation.2011.08.017. Epub 2011 Sep 3.
- Von Hoff DD, Kuhn JG, Burris HA 3rd, Miller LJ. Does intraosseous equal intravenous? A pharmacokinetic study. Am J Emerg Med. 2008 Jan;26(1):31-8. doi: 10.1016/j.ajem.2007.03.024.
- Orlowski JP, Porembka DT, Gallagher JM, Lockrem JD, VanLente F. Comparison study of intraosseous, central intravenous, and peripheral intravenous infusions of emergency drugs. Am J Dis Child. 1990 Jan;144(1):112-7. doi: 10.1001/archpedi.1990.02150250124049.
- Laurin EG, Sakles JC, Panacek EA, Rantapaa AA, Redd J. A comparison of succinylcholine and rocuronium for rapid-sequence intubation of emergency department patients. Acad Emerg Med. 2000 Dec;7(12):1362-9. doi: 10.1111/j.1553-2712.2000.tb00493.x.
- Perry JJ, Lee JS, Sillberg VA, Wells GA. Rocuronium versus succinylcholine for rapid sequence induction intubation. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD002788. doi: 10.1002/14651858.CD002788.pub2.
- Deakin CD, Nolan JP, Soar J, Sunde K, Koster RW, Smith GB, Perkins GD. European Resuscitation Council Guidelines for Resuscitation 2010 Section 4. Adult advanced life support. Resuscitation. 2010 Oct;81(10):1305-52. doi: 10.1016/j.resuscitation.2010.08.017. No abstract available. Erratum In: Resuscitation. 2011 Jan;82(1):140.
- Kleinman ME, de Caen AR, Chameides L, Atkins DL, Berg RA, Berg MD, Bhanji F, Biarent D, Bingham R, Coovadia AH, Hazinski MF, Hickey RW, Nadkarni VM, Reis AG, Rodriguez-Nunez A, Tibballs J, Zaritsky AL, Zideman D; Pediatric Basic and Advanced Life Support Chapter Collaborators. Part 10: Pediatric basic and advanced life support: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S466-515. doi: 10.1161/CIRCULATIONAHA.110.971093.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2012
Primær færdiggørelse (Faktiske)
1. august 2014
Studieafslutning (Faktiske)
1. august 2014
Datoer for studieregistrering
Først indsendt
2. juli 2012
Først indsendt, der opfyldte QC-kriterier
5. juli 2012
Først opslået (Skøn)
6. juli 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2012-03
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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