Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-22 @ 6:02 PM
Study NCT ID:
NCT01107561
Status:
COMPLETED
Last Update Posted:
2011-10-14
First Post:
2010-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Techniques for Emergency Cricothyroidotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-13', 'studyFirstSubmitDate': '2010-04-12', 'studyFirstSubmitQcDate': '2010-04-19', 'lastUpdatePostDateStruct': {'date': '2011-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to complete airway access', 'timeFrame': 'Within the 5 minutes permitted for each procedure', 'description': 'Measured in seconds as the time taken for insertion of the tube and connection of the bagging device.'}], 'secondaryOutcomes': [{'measure': 'Success', 'timeFrame': 'Within 5 minutes of the start of the procedure', 'description': 'Will be confirmed by inspection of the catheter within the tracheal lumen post procedure.'}, {'measure': 'Number of attempts', 'timeFrame': 'Within the 5 minutes permitted for each procedure', 'description': 'Number of needle insertions, sweeps with blade, guide-wire insertions, dilatation attempts and catheter insertions attempts.'}, {'measure': 'Complications', 'timeFrame': 'Within the 5 minutes permitted for each procedure', 'description': 'Penetration of posterior wall or placement of the tube outside the trachea'}, {'measure': 'Perceived difficulty', 'timeFrame': 'Prior to end of the educational session', 'description': 'Self-completed survey/questionnaire to assess level of difficulty and preference.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cricothyroidotomy', 'intubation', 'airway', 'emergency medicine', 'education'], 'conditions': ['Intubation, Intratracheal']}, 'descriptionModule': {'briefSummary': 'This educational study will examine two different techniques for training emergency residents and staff on achieving a surgical airway (called a cricothyroidotomy).', 'detailedDescription': 'Introduction: In patients that cannot be intubated or ventilated by conventional means an emergency cricothyroidotomy is a potentially life saving intervention that is the common final pathway of difficult airway algorithms. Significant debate surrounds the ideal method of performing an emergency cricothyroidotomy. The literature remains divided between the open (surgical) and closed (wire assisted, or Seldinger) techniques. We feel that these two methods are not mutually exclusive and are proposing a novel "incision first" modification to the traditional Seldinger closed technique. Making a small (1 cm) incision prior needle insertion could facilitate localization of landmarks and may improve speed or success rate of the closed Seldinger procedure.\n\nIntroduction: In patients that cannot be intubated or ventilated by conventional means an emergency cricothyroidotomy is a potentially life saving intervention that is the common final pathway of difficult airway algorithms. Significant debate surrounds the ideal method of performing an emergency cricothyroidotomy. The literature remains divided between the open (surgical) and closed (wire assisted, or Seldinger) techniques. We feel that these two methods are not mutually exclusive and are proposing a novel "incision first" modification to the traditional Seldinger closed technique. Making a small (1 cm) incision prior needle insertion could facilitate localization of landmarks and may improve speed or success rate of the closed Seldinger procedure.\n\nMethods: Using concealed allocation, this randomized controlled cross-over trial will be performed in a laboratory setting. Outcome assessment will be blinded. Both staff and resident emergency physicians will be included in this trial. We will use a well-validated swine trachea model for this study.\n\nResults: Results will be collected using standardized Case Report Forms (CRF) and independently entered into a pre-constructed Microsoft ACCESS database. The primary outcome will be time to procedure completion. Secondary outcomes will be proportion of successful cricothyroidotomy, complications and ease of procedure and ability to increase clinical confidence using this model. Paired t-tests and Fisher\'s exact test will be used to compare the outcomes and due to multiple statistical tests, a correction will be used to adjust for multiple tests (p \\< 0.025) to indicate significance.\n\nConclusions: This study will assess and evaluate both the incision first model and closed Seldinger cricothyroidotomy techniques. We will discuss the merits of each technique and the effectiveness of the model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll staff and residents presenting to a airway lab for Informed verbal consent.\n\nExclusion Criteria:\n\nNon-physicians'}, 'identificationModule': {'nctId': 'NCT01107561', 'acronym': 'CRIC', 'briefTitle': 'Different Techniques for Emergency Cricothyroidotomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Incision-first Versus Classic Seldinger Technique for Emergency Cricothyroidotomy', 'orgStudyIdInfo': {'id': 'Pro00011192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seldinger technique', 'description': 'Involves blind needle insertion through the skin into the cricoid membrane followed by insertion of the guide-wire and subsequent insertion of the tube over the guidewire.', 'interventionNames': ['Other: Seldinger technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgical airway approach', 'description': 'The classical open or surgical technique involves a vertical skin incision with blunt dissection and identification of the anatomy followed by incision of the cricoid membrane and tube insertion.', 'interventionNames': ['Device: Surgical Airway Approach']}], 'interventions': [{'name': 'Seldinger technique', 'type': 'OTHER', 'otherNames': ['Neddle approach'], 'description': 'Involves blind needle insertion through the skin into the cricoid membrane followed by insertion of the guide-wire and subsequent insertion of the tube over the guidewire', 'armGroupLabels': ['Seldinger technique']}, {'name': 'Surgical Airway Approach', 'type': 'DEVICE', 'otherNames': ['Open approach'], 'description': 'The classical open or surgical technique involves a vertical skin incision with blunt dissection and identification of the anatomy followed by incision of the cricoid membrane and tube insertion.', 'armGroupLabels': ['Surgical airway approach']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Department of Emergency Medicine', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Sandy Dong, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}, {'name': 'Warren Thirsk, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}, {'name': 'Brian H Rowe, MD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alberta'}, {'name': 'Cristina Villa-Roel, MD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Association of Emergency Physicians', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}