Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-01 @ 3:43 PM
Study NCT ID:
NCT02899351
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2016-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation', 'timeFrame': 'During 1 hour period in ICU'}, {'measure': 'Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation', 'timeFrame': 'During 1 hour period in ICU'}, {'measure': 'Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation', 'timeFrame': 'During 1 hour period in ICU'}]}, 'conditionsModule': {'conditions': ['Respiratory Complications']}, 'referencesModule': {'references': [{'pmid': '33929346', 'type': 'DERIVED', 'citation': 'Atkinson DB, Sens BA, Bernier RS, Gomez-Morad AD, Imsirovic J, Nasr VG. The Evaluation of a Noninvasive Respiratory Volume Monitor in Mechanically Ventilated Neonates and Infants. Anesth Analg. 2022 Jan 1;134(1):141-148. doi: 10.1213/ANE.0000000000005562.'}]}, 'descriptionModule': {'briefSummary': 'In this research study, the investigators want to learn more about whether the Respiratory Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the number of times per minute a breath is taken (Respiratory Rate), and the amount of air going in and out of the lungs per minute (Minute Ventilation).\n\nIt is important for medical staff to be able to collect information about breathing non-invasively because it may help determine if certain children are experiencing breathing problems sooner than the way it is currently detected.\n\nThe goal of this study is to determine if the Respiratory Volume Monitor works accurately in infants less than 12 months of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Intubated infants less than 12 months of age who are admitted to an Intensive Care Unit', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* less than 12 months of age\n* currently intubated in the ICU\n\nExclusion Criteria:\n\n* ExSpiron monitor will interfere with a healing surgical procedure site or standard of care'}, 'identificationModule': {'nctId': 'NCT02899351', 'briefTitle': 'The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants', 'orgStudyIdInfo': {'id': 'IRB-P00023229'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants less than 12 months', 'description': 'intubated infants in ICU', 'interventionNames': ['Device: Respiratory Volume Monitor']}], 'interventions': [{'name': 'Respiratory Volume Monitor', 'type': 'DEVICE', 'otherNames': ['ExSpiron'], 'armGroupLabels': ['Infants less than 12 months']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Viviane Nasr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiac Anesthesiologist', 'investigatorFullName': 'Viviane Nasr', 'investigatorAffiliation': "Boston Children's Hospital"}}}}