Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-04 @ 9:27 AM
Study NCT ID:
NCT06487104
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-01
First Post:
2024-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of TrachPhone in Tracheostomized Patients
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': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, two-armed randomized controlled trial with a subsequent feasibility phase, transitioning control-group patients to investigational device arm'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2024-04-05', 'studyFirstSubmitQcDate': '2024-07-02', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of suctioning per day', 'timeFrame': 'At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)', 'description': 'Times per day suctioning is required'}], 'secondaryOutcomes': [{'measure': 'Time needed for suctioning', 'timeFrame': 'At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)', 'description': 'Minutes per day of suctioning'}, {'measure': 'Quality of secretion', 'timeFrame': 'At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)', 'description': 'Amount and color of secretion'}, {'measure': 'Quality of Life by EQ-5D-5L', 'timeFrame': 'At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)', 'description': 'Patient reported, the descriptive system assesses health in five dimensions, from which a health state index score is calculated, range from 0 to 1, with higher scores indicating higher health utility'}, {'measure': 'Use of TrachPhone', 'timeFrame': 'At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)', 'description': '% of patients using TrachPhone/tolerating TrachPhone recorded by study specific questionnaire'}, {'measure': 'Patient preference', 'timeFrame': 'Upon discharge from the hospital (on average after 3 weeks)', 'description': '% of patients (participants that were assigned to Arm 2) recorded by study specific questionnaire'}, {'measure': 'Nurse and therapy team feedback', 'timeFrame': 'Upon discharge of the last participant, on average after 1 year', 'description': 'Staff impression and preference measured by nurse survey'}, {'measure': 'Nursing time regarding device use', 'timeFrame': 'At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)', 'description': 'Minutes per day spent on device handling, recorded by nurse diary keeping, 3-day collection'}, {'measure': 'Adherence to use of devices', 'timeFrame': 'At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)', 'description': 'Hours of use of each humidification method, recorded by study specific questionnaire'}, {'measure': 'Patient communication', 'timeFrame': 'At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)', 'description': 'Communication by Therapy Outcome Measure for Voice Impairment (TOMS, score 0-5, higher score meaning no impairment)'}, {'measure': 'Voice Quality', 'timeFrame': 'At Baseline, after 10 days, and every 10 days until discharge from hospital (on average after 3 weeks)', 'description': 'Patient reported, for participants speaking, through study specific questionnaire'}, {'measure': 'Patient mobility', 'timeFrame': 'Upon discharge of the last participant, on average after 1 year', 'description': 'Staff perception of patient mobility and ease of transportation, measured though study specific questionnaires and nurse survey'}, {'measure': 'Oxygen needs', 'timeFrame': 'At Baseline, T1 follow-up, and TX follow-ups every 10-14 days until discharge', 'description': 'Weaning of oxygen time needed measured by peripheral oxygen saturation (%) recorded in patient charts. Only for monitoring reasons.'}, {'measure': 'Adverse Events', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Any incidents reported throughout study duration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heat and Moisture Exchangers', 'Secretion'], 'conditions': ['Tracheostomy']}, 'descriptionModule': {'briefSummary': 'The use of Heat and Moisture Exchangers (HMEs) and their positive impact on pulmonary health have been extensively studied in patients with head and neck cancer but have not been systematically explored in other patient populations breathing through a neck stoma.\n\nThe objective of this clinical investigation is to compare the use of HMEs to the use of External Humidifiers (EHs) on pulmonary secretion management, their usability and safety, for humidifying inhaled air in patients that received a tracheostomy due to a neurological condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tracheostomy patient outside critical care\n* Self-ventilating via a tracheostomy tube, independent of cuff status\n* 18 years or older\n\nExclusion Criteria:\n\n* Patients with tidal volume beyond recommended range (50-1000 ml)\n* Dehydration\n* Very heavy/excessive secretion from the lungs and airways (requiring more frequently tracheal suction, more than hourly suctioning)\n* High oxygen need (FiO2 \\> 0.4)\n* Acutely deteriorating patient'}, 'identificationModule': {'nctId': 'NCT06487104', 'briefTitle': 'Use of TrachPhone in Tracheostomized Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atos Medical AB'}, 'officialTitle': 'Safety, Feasibility, and Impact on Pulmonary Secretion Management Comparing the Use of TrachPhone and External Humidifier After Tracheostomy', 'orgStudyIdInfo': {'id': 'TrachPhone'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 - HME', 'description': '24/7 use of TrachPhone HME for the entirety of study', 'interventionNames': ['Device: TrachPhone HME']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 - EH', 'description': '24/7 use of EH until first follow-up (T1), then 24/7 use of TrachPhone HME for the remainder of the study participation.', 'interventionNames': ['Device: TrachPhone HME', 'Device: External Humidifier (Usual Care)']}], 'interventions': [{'name': 'TrachPhone HME', 'type': 'DEVICE', 'description': 'Use of TrachPhone HME for humidification of inhaled air in tracheostomized patients.\n\nThe TrachPhone HME is an HME specifically designed for tracheostomy patients.', 'armGroupLabels': ['Arm 1 - HME', 'Arm 2 - EH']}, {'name': 'External Humidifier (Usual Care)', 'type': 'DEVICE', 'description': 'Usual care routines using an External Humidifier for humidification of inhaled air in tracheostomized patients.', 'armGroupLabels': ['Arm 2 - EH']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal London Hospital, Barts Health NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Amanda Thomas, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Royal London Hospital, Barts Health NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atos Medical AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}