Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 7:01 AM
Study NCT ID:
NCT01489150
Status:
COMPLETED
Last Update Posted:
2013-05-16
First Post:
2011-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of EtCO2 as a PaCO2 Predictor Under Non Invasive Ventilation (NIV) in Cases of Acute Hypercapnic Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D006935', 'term': 'Hypercapnia'}], 'ancestors': [{'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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-15', 'studyFirstSubmitDate': '2011-12-02', 'studyFirstSubmitQcDate': '2011-12-07', 'lastUpdatePostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between EtCO2,PaCO2 and PaCO2 variation under NIV during both spontaneous expiration and prolonged expiration', 'timeFrame': 'Sixty minutes', 'description': 'Comparison between EtCO2,PaCO2 and PaCO2 variation under NIV during both spontaneous expiration and prolonged expiration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute respiratory failure', 'Hypercapnia', 'Non invasive ventilation', 'End-tidal CO2'], 'conditions': ['Hypercapnic Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '25852962', 'type': 'DERIVED', 'citation': 'Piquilloud L, Thevoz D, Jolliet P, Revelly JP. End-tidal carbon dioxide monitoring using a naso-buccal sensor is not appropriate to monitor capnia during non-invasive ventilation. Ann Intensive Care. 2015 Feb 12;5:2. doi: 10.1186/s13613-014-0042-8. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'In patients treated by Non invasive ventilation (NIV) due to acute hypercapnic respiratory failure, the interest of using the End-tidal Co2 measurement device "Capnostream" to evaluate PaCo2 and PaCo2 variations over time will be evaluated. Measurements will be done under normal expiration and under prolonged active and passive expiration maneuvers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Intensive care unit patients equipped with arterial line requiring non invasive ventilation because of acute hypercapnic respiratory failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patient equipped with arterial line\n* NIV requirement\n* Hypercapnia: PaCO2 \\> 45mmhg\n\nExclusion Criteria:\n\n* Severe hemodynamic instability\n* Severe psychiatric disorders\n* nasal lesions\n* denied consent'}, 'identificationModule': {'nctId': 'NCT01489150', 'briefTitle': 'Use of EtCO2 as a PaCO2 Predictor Under Non Invasive Ventilation (NIV) in Cases of Acute Hypercapnic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Use of EtCO2 and Prolonged Expiratory Maneuvers as a PaCO2 Predictor in Cases of Acute Hypercapnic Respiratory Failure', 'orgStudyIdInfo': {'id': 'EtCO2-NIV'}}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Intensive care and burn unit, University Hospital of Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Philippe Jolliet, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Lausanne Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Prof. Philippe Jolliet', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}