Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT04346420
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2020-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-05', 'studyFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2020-04-13', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in O2 output', 'timeFrame': 'At baseline and 30 minutes after wearing both systems', 'description': 'The O2 output will be adjusted to maintain a SpO2 of 94% using both systems for administering O2. The O2 flow will be read from the position of the ball in flow meters.'}], 'secondaryOutcomes': [{'measure': 'Comfort with the interfaces', 'timeFrame': '30 minutes after wearing both systems', 'description': 'A Likert scale from 0 to 5 will be used to measure the subjective comfort of the patient while wearing the standard interface for administering O2 and/or the DTM'}, {'measure': 'Changes in PaO2', 'timeFrame': 'At baseline and 30 minutes after wearing DTM', 'description': 'Oxygen tension (PaO2) in mmHg will be analyzed from a sample taken from the arterial system'}, {'measure': 'Changes in PaCO2', 'timeFrame': 'At baseline and 30 minutes after wearing DTM', 'description': 'Carbon dioxide tension (PaCO2) in mmHg will be analyzed from a sample taken from the arterial system.'}, {'measure': 'Changes in pH', 'timeFrame': 'At baseline and 30 minutes after wearing DTM', 'description': 'Potential of Hydrogen (pH) will be analyzed from a sample taken from the arterial system.'}, {'measure': 'Changes in respiratory rate', 'timeFrame': 'At baseline and 30 minutes after wearing both systems', 'description': 'Respiratory rate is measured during one minute by visual inspection.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID', 'Hypoxemia']}, 'descriptionModule': {'briefSummary': 'This study will investigate the impact of the Double-Trunk Mask (DTM) on the reduction of oxygen titration in patients with severe hypoxemia.', 'detailedDescription': 'The Double-Trunk Mask (DTM) is a device designed to increase the fraction of inspired oxygen in patients who receive oxygen therapy. The mask is composed of a regular aerosol mask with corrugated tubing (15 cm length) inserted into two lateral holes.\n\nEach included patient will wear standard nasal cannula in addition to the Double-Trunk Mask for 30 minutes, then only their standard oxygen interface for the next 30 minutes. While maintaining the oxygen saturation by pulse oximetry (SpO2) at a target value of 94%, the impact of the DTM will be assessed by measuring the change of oxygen flow given to the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COVID-19\n* SpO2 between 92 and 96% with low-flow oxygen therapy (\\< 15 L/min).\n\nExclusion Criteria:\n\n* Chronic obstructive pulmonary disease or other chronic respiratory disease\n* Confusion\n* Hypoxemia corrected (SpO2 ≥ 96%) with O2 flow ≤ 3 L/min\n* Contra-indications to arterial blood gas sampling (peripheral arteriopathy, bleeding disorder)'}, 'identificationModule': {'nctId': 'NCT04346420', 'briefTitle': 'Impact of the Double-Trunk Mask on Oxygenation Titration in COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Impact of the Double-Trunk Mask on Oxygenation Titration in Patients With COVID-19', 'orgStudyIdInfo': {'id': 'DTM-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'O2 DTM+', 'description': 'The standard nasal cannula interface is accompanied with the DTM', 'interventionNames': ['Device: Double-Trunk Mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'O2 DTM-', 'description': 'The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient, without the DTM', 'interventionNames': ['Other: Standard interface']}], 'interventions': [{'name': 'Standard interface', 'type': 'OTHER', 'description': 'The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%.', 'armGroupLabels': ['O2 DTM-']}, {'name': 'Double-Trunk Mask', 'type': 'DEVICE', 'description': 'The standard nasal cannula interface accompanied with the DTM is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%.', 'armGroupLabels': ['O2 DTM+']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Poncin', 'investigatorAffiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}}}}