Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 5:27 PM
Study NCT ID:
NCT01156233
Status:
COMPLETED
Last Update Posted:
2013-02-12
First Post:
2010-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tube Tip Position in Orally Intubated 0-4year Old Children: Assessment of the Precision of Two Clinical Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-09', 'studyFirstSubmitDate': '2010-06-30', 'studyFirstSubmitQcDate': '2010-07-01', 'lastUpdatePostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Localisation and precision of the tip of the endotracheal tube (TET) in the trachea', 'timeFrame': '10 minutes', 'description': 'The study intends to determine the location and precision of the TET within the trachea that results from the use of two techniques. The measurements take place after the induction of the anesthesia and before surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['evaluating precision of tube tip position with two methods'], 'conditions': ['Intubation, Endotracheal']}, 'descriptionModule': {'briefSummary': 'In pediatric anesthesia it is very important to place the endotracheal tube into the right position. This study compares two clinical location methods. The hypothesis means that the two techniques have the same precision of the location of the tip position of a cuffed MICROCUFF (Kimberly-Clark)endotracheal tube.', 'detailedDescription': 'Appropriate location of the tip of an endotracheal tube (TET), in relation to the carina and vocal cords, is of great importance in pediatric anesthesia. A not optimal laying tube causes life threatening consequences. Therefore, it is very essential to have reliable methods how to place the tube tip in regard of the precision of the localisation. There are no standardized methods how to accomplish a precise position. The study compares two most applied techniques. The first one is the cuff palpation technique (CPT), the second one the deliberate right mainstem intubation technique (RMT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 0-4 years\n* ASA I-II\n* requiring endotracheal tube for surgical/diagnostic procedures\n\nExclusion Criteria:\n\n* patients with abnormal airway anatomy\n* kyphoscoliosis\n* syndromes known to affect airway anatomy'}, 'identificationModule': {'nctId': 'NCT01156233', 'briefTitle': 'Tube Tip Position in Orally Intubated 0-4year Old Children: Assessment of the Precision of Two Clinical Techniques', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Endotracheal Tube Tip Position in Orally Intubated 0-4 Year Old Children: Comparative Assessment of the Precision of Two Clinical Techniques', 'orgStudyIdInfo': {'id': 'UKBB_ANA_ TET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cuff palpation technique', 'description': "Cuff palpation by the investigator's finger.", 'interventionNames': ['Procedure: Anesthesia induction']}, {'type': 'EXPERIMENTAL', 'label': 'Withdrawing tube technique', 'description': 'Identification of the tube by withdrawing until good quality breath sounds', 'interventionNames': ['Procedure: Anesthesia induction']}], 'interventions': [{'name': 'Anesthesia induction', 'type': 'PROCEDURE', 'otherNames': ['Pediatric endotracheal tube. Microcuff, Kimberly-Clark.'], 'description': 'Cuff palpation technique: identification of the cuff position in the trachea by palpation.', 'armGroupLabels': ['Cuff palpation technique']}, {'name': 'Anesthesia induction', 'type': 'PROCEDURE', 'otherNames': ['Pediatric endotracheal tube, Microcuff, Kimberly-Clark'], 'description': 'Right mainstem intubation, identification of the tube tip position in the trachea by withdrawing the tube from the right mainstem until good quality breath sound in the left axilla are available.', 'armGroupLabels': ['Withdrawing tube technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4005', 'city': 'Basel', 'state': 'Basel', 'country': 'Switzerland', 'facility': 'Universitätskinderspital beider Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Franz Frei, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Childrens Hospital beider Basel Postfach CH 4005 Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Franz Frei', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Franz Frei', 'investigatorFullName': 'Franz Frei', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}