Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04155892
Status:
COMPLETED
Last Update Posted:
2025-11-04
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Extubation Criteria in Children With Upper Respiratory Infection (URI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 760}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2019-11-05', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of successful extubation in children with at least 3 of the five criteria present', 'timeFrame': 'Day 1', 'description': 'The 5 criteria (facial grimace, eye opening, conjugate gaze, purposeful movement, and tidal volume \\> 5 cc/kg)'}, {'measure': 'Rate of participants with an extubation requiring intervention', 'timeFrame': 'Day 1', 'description': 'The quality of extubation will be graded as successful, intervention required or major intervention required'}, {'measure': 'Rate of participants with an extubation requiring major intervention', 'timeFrame': 'Day 1', 'description': 'The quality of extubation will be graded as successful, intervention required or major intervention required'}, {'measure': 'Rate of participants with a successful extubation', 'timeFrame': 'Day 1', 'description': 'The quality of extubation will be graded as successful, intervention required or major intervention required'}], 'secondaryOutcomes': [{'measure': 'Rate of on time and anticipated discharge from the hospital', 'timeFrame': 'Up to 5 days after discharge'}, {'measure': 'Rate of patients seeking additional care following discharge for respiratory related symptoms', 'timeFrame': 'Up to 5 days after discharge'}, {'measure': 'Preoperative room air oxygen saturation', 'timeFrame': 'Day 1'}, {'measure': 'Rate of extubation success per the number of factors present at time of extubation', 'timeFrame': 'Day 1', 'description': 'Rate of success at the presence of 3 to 6 predictors (eye opening, facial grimace, purposeful movement, conjugate gaze, tidal volume \\> 5 cc/kg, and ETCO2\\<56 mmHg) at time of extubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extubation criteria', 'Pediatric Anesthesia', 'Outpatient surgery'], 'conditions': ['Upper Respiratory Tract Infections']}, 'descriptionModule': {'briefSummary': "The investigators are currently completing a data collection to try to optimize pediatric patients' preoperative screening, in the setting of an upper respiratory infection.", 'detailedDescription': 'The objectives of this study are to evaluate various extubation criteria and their predictive value for successful extubation in non-cardiac surgical procedures. To evaluate the predictive value of room air oxygen and an original preoperative URI questionnaire in pediatric patients with URI or URI symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* All study participants must be \\< 8 years of age and undergoing general anesthesia and surgery with an endotracheal tube\n* The URI group will be participants with a score of at least 3 on our pre-operative URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1.\n* The non URI group will be participants undergoing elective procedures with no URI symptom or recent URI. Defined as no URI or "allergy" symptom within the past 6 weeks and a score of 1 or less on the URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All study participants must be undergoing general anesthesia and surgery with an endotracheal tube\n* The URI group will be participants with a score of at least 3 on our pre-operative URI survey, with planned airway instrumentation with an endotracheal tube (ETT) for their surgical procedure who are to be discharged same day or on postoperative day 1.\n* The non URI group will be participants undergoing elective procedures with no URI symptom or recent URI. Defined as no URI or "allergy" symptom within the past 6 weeks and a score of 1 or less on the URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1.\n\nExclusion Criteria:\n\n* History of home oxygen use or ventilator dependence,\n* Patients undergoing emergent procedures.\n* Patients with cyanotic congenital heart disease.\n* Patients receiving a surgical procedure where the duration of post procedure\n* admission is anticipated to be greater or equal to 2 postoperative days.\n* Patients undergoing anesthesia for imaging procedures alone.\n* Patients who are extubated deep intentionally.\n* Patients intended to be managed with supraglottic airway.\n* Patients undergoing total IV anaesthesia (TIVA).'}, 'identificationModule': {'nctId': 'NCT04155892', 'briefTitle': 'Evaluation of Extubation Criteria in Children With Upper Respiratory Infection (URI)', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'A Prospective Observational Study Evaluating Extubation Criteria in Children Less Than 8 Years of Age With Upper Respiratory Infection Undergoing Outpatient or Day Hospital Based Surgery', 'orgStudyIdInfo': {'id': 'IRB00056059'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'URI group', 'description': 'This group includes participants \\<8 years of age undergoing elective procedures with a score of at least 3 on our pre-operative URI survey.'}, {'label': 'non-URI group', 'description': 'This group includes participants \\<8 years of age undergoing elective procedures with no URI symptoms or recent URI.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Thomas Templeton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}