Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-30 @ 4:03 PM
Study NCT ID:
NCT01634867
Status:
WITHDRAWN
Last Update Posted:
2014-12-23
First Post:
2012-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Rapid Sequence Intubation (RSI) Drug Delivery Using Intraosseous (IO) and Intravenous (IV) Access in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No subject enrollment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-19', 'studyFirstSubmitDate': '2012-07-02', 'studyFirstSubmitQcDate': '2012-07-05', 'lastUpdatePostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from determination of need for vascular access for rapid sequence intubation to administration of first does of paralytic agent.', 'timeFrame': 'during rapid sequence intubation procedure, average expected time frame 30 minutes'}, {'measure': 'Time from vascular access to intubation first attempt, as indicated by the first attempt to visualize the larynx with the laryngoscope.', 'timeFrame': 'during rapid sequence intubation procedure, average expected time frame 30 minutes'}, {'measure': 'time from vascular access to successful intubation', 'timeFrame': 'during rapid sequence intubation procedure, average expected time frame 30 minutes'}, {'measure': 'number of attempts necessary for successful intubation', 'timeFrame': 'during rapid sequence intubation procedure, average expected time frame 30 minutes'}], 'secondaryOutcomes': [{'measure': 'Intubation difficulty', 'timeFrame': 'during rapid sequence intubation procedure, average time frame 30 minutes', 'description': '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.'}, {'measure': 'operator satisfaction with intubating conditions', 'timeFrame': 'during rapid sequence intubation procedure, average time frame 30 minutes'}, {'measure': 'failure rate of endotracheal intubation', 'timeFrame': 'during rapid sequence intubation procedure, average time frame 30 minutes', 'description': 'failure rate of endotracheal intubation and requirement for alternative airway management.'}, {'measure': 'Time from presentation of patient to vascular access established', 'timeFrame': 'during rapid sequence intubation procedure, average time frame 30 minutes'}, {'measure': 'Determine the incidence of short term catheter related complications for each technique', 'timeFrame': 'during emergency department stay, average time frame 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Airway Control']}, 'referencesModule': {'references': [{'pmid': '21856044', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9416711', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21893125', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20956049', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20956258', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19325359', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18082778', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1688484', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11099426', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18425883', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients in the emergency department with airway difficulties requiring rapid sequence intubation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects requiring rapid sequence intubation for whom rocuronium is chosen as the paralytic agent.\n* the operator chooses to place a peripheral intravenous or powered intraosseous catheter to permit rapid sequence intubation.\n\nExclusion Criteria:\n\n* subjects in whom vascular access for rapid sequence intubation drug administration was established prior to arrival to the emergency department.'}, 'identificationModule': {'nctId': 'NCT01634867', 'briefTitle': 'Observational Study of Rapid Sequence Intubation (RSI) Drug Delivery Using Intraosseous (IO) and Intravenous (IV) Access in Pediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vidacare Corporation'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2012-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intraosseous (IO) drug delivery', 'description': 'patients in whom intraosseous (IO) vascular access has been established for rapid sequence intubation drug delivery.'}, {'label': 'Peripheral intravenous (IV) drug delivery', 'description': 'patients in whom peripheral intravenous (IV) vascular access has been established for rapid sequence intubation drug delivery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': "Omaha Children's Hospital and Medical Center", 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Edward Truemper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vidacare Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}