Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT01845233
Status:
COMPLETED
Last Update Posted:
2014-08-25
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of Non-invasive Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007040', 'term': 'Hypoventilation'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-22', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Technical drift of Transcutaneous Co2 measurement during 8 hours monitoring', 'timeFrame': 'One night study'}, {'measure': 'Interscorer variability when scoring polygraphy during Non invasive ventilation', 'timeFrame': 'one night study'}, {'measure': 'Comparing rate of event data from ventilator software with manually scored polygraphy during non invasive ventilation', 'timeFrame': 'Single night study'}, {'measure': 'Accuracy of Transcutaneous monitoring of Co2 compared to arterial carbon dioxide partial pressure', 'timeFrame': 'single night study'}, {'measure': 'Frequency of sleep related breathing events during non invasive ventilation', 'timeFrame': 'single night study'}], 'primaryOutcomes': [{'measure': 'Frequency of transcutaneous co2 revealing sleep hypoventilation, when nocturnal pulseoximeter is normal', 'timeFrame': 'single night study'}], 'secondaryOutcomes': [{'measure': 'Frequency of patient-ventilator asynchrony during non invasive ventilation ?', 'timeFrame': 'Single night study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypoventilation']}, 'referencesModule': {'references': [{'pmid': '30366581', 'type': 'DERIVED', 'citation': 'Aarrestad S, Qvarfort M, Kleiven AL, Tollefsen E, Skjonsberg OH, Janssens JP. Diagnostic accuracy of simple tools in monitoring patients with chronic hypoventilation treated with non-invasive ventilation; a prospective cross-sectional study. Respir Med. 2018 Nov;144:30-35. doi: 10.1016/j.rmed.2018.09.015. Epub 2018 Sep 26.'}, {'pmid': '29229100', 'type': 'DERIVED', 'citation': 'Aarrestad S, Qvarfort M, Kleiven AL, Tollefsen E, Skjonsberg OH, Janssens JP. Sleep related respiratory events during non-invasive ventilation of patients with chronic hypoventilation. Respir Med. 2017 Nov;132:210-216. doi: 10.1016/j.rmed.2017.10.025. Epub 2017 Nov 2.'}, {'pmid': '26874895', 'type': 'DERIVED', 'citation': 'Aarrestad S, Tollefsen E, Kleiven AL, Qvarfort M, Janssens JP, Skjonsberg OH. Validity of transcutaneous PCO2 in monitoring chronic hypoventilation treated with non-invasive ventilation. Respir Med. 2016 Mar;112:112-8. doi: 10.1016/j.rmed.2016.01.017. Epub 2016 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether clinical examination, report from ventilator software, nocturnal Sp02 and daytime arterial blood gas are sufficient as screening tools to reveal clinical relevant problems with patients receiving long term treatment with non invasive ventilation.', 'detailedDescription': 'Patient with chronic hypoventilation with stable on long term treatment (LTMV) with non-invasive ventilation for at least 3 month taking part of our LTMV program will be included.\n\nIn addition to clinical examination,report from ventilator software, nocturnal Sp02 and daytime arterial blood gas all patients will be investigated with sleep polygraphy and transcutaneous Co2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic hypoventilation treated with long term mechanical ventilation', 'healthyVolunteers': False, 'eligibilityCriteria': '* Admitted to our unit for optimal treatment of long term non invasive ventilation\n* Readmitted for control after 6-8 weeks\n* Then treated for at least 3 month with long term non invasive ventilation outside of hospital.\n* Informed written consent\n\nExclusion Criteria:\n\n* Under 18 years old\n* Lack of cooperation\n* Pregnant\n* Acute exacerbation last 3 month leading to hospital admission.\n* Change of treatment last 3 month'}, 'identificationModule': {'nctId': 'NCT01845233', 'briefTitle': 'Monitoring of Non-invasive Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Monitoring of Non-invasive Ventilation', 'orgStudyIdInfo': {'id': '2012/1142(REK)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non invasive ventilation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0471', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Sigurd aarrestad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'Trondheim University Hospital', 'class': 'OTHER'}, {'name': 'University Hospital, Geneva', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}