Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-03-02 @ 8:53 AM
Study NCT ID:
NCT03614806
Status:
COMPLETED
Last Update Posted:
2020-06-29
First Post:
2017-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Transcutaneous Vs End-tidal CO2 Pressure Measurements in Hyperventilation Syndrome Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016857', 'term': 'Hypocapnia'}, {'id': 'D000472', 'term': 'Alkalosis, Respiratory'}, {'id': 'D006985', 'term': 'Hyperventilation'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000471', 'term': 'Alkalosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open label study prospective'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-26', 'studyFirstSubmitDate': '2017-11-29', 'studyFirstSubmitQcDate': '2018-07-30', 'lastUpdatePostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trans-cutaneous Carbon Dioxide pressure', 'timeFrame': 'during hyperventilation test', 'description': 'Trans-cutaneous Carbon Dioxide pressure measurements diagnostic of hyperventilation syndrome will be evaluated by comparing it with that of standard'}, {'measure': 'End-tidal Carbon Dioxide partial pressure', 'timeFrame': 'during hyperventilation test', 'description': 'End-tidal Carbon Dioxide partial pressure measurement. Consistency of the diagnostic conclusions reached by either test will be analyzed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperventilation Syndrome', 'Hypocapnia', 'Alkalosis, Respiratory', 'Hyperventilation']}, 'descriptionModule': {'briefSummary': 'Hyper Ventilation Syndrome is a frequent disease affecting adults whose diagnosis is often belated or even unrecognized due to the lack of "gold standard" criteria. Its diagnosis currently relies on the Nijmegen score associated with a PetCO2 assesment using a hyperventilation provocation test. Correlation between Nijmegen Questionnaire scores and PetCO2 appears highly variable. PtcCO2 monitoring is a noninvasive alternative method providing a continuous estimation of arterial CO2 pressure (PaCO2) which could represent an advantageous alternative to PetCO2 measurements. Several reports have demonstrated that PtcCO2 monitoring reflects more faithfully PaCO2 than PetCO2, no study have evaluated its value in this indication.\n\nThe primary aim of the study is to compare the diagnostic value of PtcPCO2 monitoring with PetCO2, the method currently used.\n\nIncluded patient will be invited to fill in the Nijmegen questionnaire and an ambient air gas measurement will be performed. PtcCO2 (mmHg) will be simultaneously measured during hyperventilation test. Nijmegen score signs reproduced by the test will be analysed. HVS diagnosis will be assessed by usual criteria (PetCO2 \\<30 mmHg at the end of hyperventilation test or under the PetCO2 value at rest, Nijmegen score\\> 23).\n\nPtcCO2 data will be blinded interpreted later. We will compare if PetCO2 and PtcCO2 leads to the same diagnosis or not.', 'detailedDescription': 'Primary Goal:\n\nShow that the use of either of the two pCO2 measurements leads to the same diagnostic conclusion in HVS diagnosis with a likelihood greater than 80 %.\n\nSecondary Outcome Measures :\n\nEvaluate the correlation between PtcCO2 and PtcCO2 measurements Evaluate tolerance to the hyperventilation test\n\nInclusion Criteria :\n\n1. The patient must have reached the age of the civil majority (≥ 18 yo)\n2. All patients refered to the Physiology department of Rouen University Hospital, France, for an hyperventilation test\n3. The patient must be a member or beneficiary of a health insurance program\n4. The patient must have given his / her free and informed consent and signed the consent\n\nExclusion Criteria :\n\n1. Sepsis\n2. Hypercapnia (PaCO2 \\> 50mmHg)\n3. Patient treated by long-term oxygen therapy\n4. Subjects under judicial protection, or adults under any kind of guardianship or under judicial control\n5. Pregnancy or breastfeeding women\n6. Electrolytic unbalance\n7. Hyperthyroidism\n8. Neurological disease\n9. Probability of drug-induced hyperventilation (progestagens , aspirin, beta agonists)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient must have reached the age of the civil majority (≥ 18 yo)\n2. All patients refered to the Physiology department of Rouen University Hospital, France, for an hyperventilation test\n3. The patient must be a member or beneficiary of a health insurance program\n4. The patient must have given his / her free and informed consent and signed the consent\n\nExclusion Criteria:\n\n1. Sepsis\n2. Hypercapnia (PaCO2 \\> 50mmHg)\n3. Patient treated by long-term oxygen therapy\n4. Subjects under judicial protection, or adults under any kind of guardianship or under judicial control\n5. Pregnancy or breastfeeding women\n6. Electrolytic unbalance\n7. Hyperthyroidism\n8. Neurological disease\n9. Probability of drug-induced hyperventilation (progestagens , aspirin, beta agonists)'}, 'identificationModule': {'nctId': 'NCT03614806', 'acronym': 'TCvsPETCO2', 'briefTitle': 'Comparison of Transcutaneous Vs End-tidal CO2 Pressure Measurements in Hyperventilation Syndrome Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Transcutaneous Carbon Dioxide Pressure (tcPCO2) Monitoring Vs End-tidal Partial Pressure Carbon Dioxide (PetCO2) Measurement in the Diagnosis of Hyperventilation Syndrome (HVS) (TCvsPETCO2 )', 'orgStudyIdInfo': {'id': '2017/128/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients tested for hyperventilation', 'description': 'Simultaneous Transcutaneous and End-tidal CO2 measurements. Eligible patients will be first invited to fill in the Nijmegen questionnaire. Then, in an hyperventilation test, transcutaneous Carbon Dioxide Pressure will be recorded simultaneously with the standard End-tidal Carbon Dioxide Pressure measurement.', 'interventionNames': ['Diagnostic Test: Simultaneous Transcutaneous and End-tidal CO2 measurements']}], 'interventions': [{'name': 'Simultaneous Transcutaneous and End-tidal CO2 measurements', 'type': 'DIAGNOSTIC_TEST', 'description': 'Included patients will be invited to fill in the Nijmegen questionnaire. During the hyperventilation test, PtcCO2 (mmHg) will be recorded simultaneously with the standard End-tidal Cpartial pressure CO2 measurement', 'armGroupLabels': ['Patients tested for hyperventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Physiology department of Rouen University Hospital,', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'ARTAUD-MACARI Elise, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}