Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT01857635
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2013-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of TpCO2 (Transcutaneous CO2 Measurement) as PaCO2 Predictor During NIV in Case 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': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-07', 'studyFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2013-05-15', 'lastUpdatePostDateStruct': {'date': '2015-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between TpCO2 (transcutaneous non invasive CO2 partial pressure measurement) and PaCO2 (obtained by blood gas analysis) values during NIV treatment.', 'timeFrame': 'sixty minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute respiratory failure', 'Hypercapnia', 'Non invasive ventilation', 'Transcutaneous CO2 measurement'], 'conditions': ['Hypercapnic Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'In patients suffering from hypercapnic respiratory failure and treated by non invasive ventilation (NIV), the interest of using transcutaneous CO2 measurement to evaluate PaCO2 and PaCO2 variation over time is unknown and will be evaluated in this study. Measurements will be done during one-hour NIV treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Intensive care unit patients equipped with an arterial line and requiring non invasive ventilation because of acute hypercapnic respiratory failure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patient equipped with an arterial line\n* NIV treatment prescribed by the clinician in charge\n* Hypercapnia defined by PaCO2\\> 42mmHg\n\nExclusion Criteria:\n\n* Severe hemodynamic instability\n* Severe psychiatric disorders\n* Denied consent\n* Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT01857635', 'acronym': 'TpCO2-NIV', 'briefTitle': 'Use of TpCO2 (Transcutaneous CO2 Measurement) as PaCO2 Predictor During NIV in Case of Acute Hypercapnic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Use of TpCO2 (Transcutaneous CO2 Measurement)as PaCO2 Predictor During Non Invasive Ventilation (NIV) in Case of Acute Hypercapnic Respiratory Failure', 'orgStudyIdInfo': {'id': 'TpCO2-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, Prof', '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'}}}}