Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT04354220
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2019-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Capnography Monitoring in Ventilated Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001784', 'term': 'Blood Gas Analysis'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2019-04-16', 'studyFirstSubmitQcDate': '2020-04-17', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of end-tidal Carbon Dioxide (PetCO2) values in comparison to arterial Carbon Dioxide (PaCO2) values in invasively and non-invasively ventilated critically ill children without lung or heart disease', 'timeFrame': 'On average every participant will be assessed for 5 days', 'description': 'Mean absolute measurement difference between simultaneously obtained PaCO2 and PetCO2 values (bias) and their 95% limits of agreement (precision) in children and newborns without cardiopulmonary dysfunction. Units of measure will be in kilopascal (kPa) for PetCO2 and PaCO2, respectively.'}], 'secondaryOutcomes': [{'measure': 'Accuracy of end-tidal Carbon Dioxide (PetCO2) values in comparison to arterial Carbon Dioxide (PaCO2) values in invasively and non-invasively ventilated critically ill children with lung and or heart disease', 'timeFrame': 'On average every participant will be assessed for 5 days', 'description': 'Cardiopulmonary function-dependent mean absolute measurement difference between simultaneously obtained PaCO2 and PetCO2 values (bias) and their 95% limits of agreement (precision) in children and newborns with cardiopulmonary dysfunction. Units of measure will be in kilopascal (kPa) for PetCO2 and PaCO2, respectively.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['capnography', 'end-tidal CO2', 'critically ill children', 'ventilated', 'accuracy'], 'conditions': ['Child, Only', 'Infant, Newborn, Diseases', 'Critical Illness', 'ARDS, Human', 'Heart Defects, Congenital', 'Lung Diseases, Obstructive', 'Lung Diseases, Interstitial']}, 'descriptionModule': {'briefSummary': 'End-tidal CO2 measurements in children will be assessed for their accuracy with arterial CO2 measurements.', 'detailedDescription': 'End-tidal and arterial CO2 measurements will be performed in invasively and non-invasively ventilated critically ill children. The endtidal CO2 values will assessed for their accuracy with respect to different underlying diseases and conditions of the children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '1 Hour', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill infants and children under invasive and non-invasive mechanical ventilation, regardless of their underlying acute or chronic diseases, as long as an arterial line for blood gas analyses is in situ.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children on pressure controlled mechanical invasive or non-invasive ventilation on the Paediatric Intensive Care Unit of the University Children's Hospital Zurich\n* Newborns with a birthweight of at least 2.0 kg\n* Newborns with an age of at least 1 hour (age \\> 60 minutes)\n* Children up to the last day of the 13th year of living\n* Ability of care taker or patient to understand verbal and written instructions and the general consent or informed consent in German or English\n* Obtained written general or informed consent as documented by signature\n* Available arterial line, i.e. a specific catheter inserted in an artery\n\nExclusion Criteria:\n\n* Care taker or participant unable for linguistic, mental or other reasons or unwilling to understand verbal or written information and to give written informed consent in German or English\n* Care taker not available\n* Newborns with a birthweight below 2.0 kg\n* Newborns younger than 1 hour (age \\<60 minutes)\n* Children with an age of 14 years onwards\n* Missing arterial line\n* Patients dependent on any other kind of respiratory support that is not compatible with the PcCO2-sensor or where a high leakage in the respiratory circuit makes PcCO2 measurements impossible (nasal mask ventilation, low-flow-/high-flow-ventilation, rebreathing mask, high- frequency-oscillation)\n* Patients where the investigators act on the assumption that mechanical ventilation will be discontinued and/or the arterial line will be removed within 6 hours or where only one pair of values (arterial and endtidal CO2) can be compared\n* Patients with a cyanotic shunt lesion with a weight of 15 kg or above"}, 'identificationModule': {'nctId': 'NCT04354220', 'briefTitle': 'Capnography Monitoring in Ventilated Children', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital, Zurich"}, 'officialTitle': 'Accuracy of Capnography Monitoring in Invasively and Non-invasively Ventilated Children', 'orgStudyIdInfo': {'id': 'KISPI-CAPNO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'no shunt, no lung injury', 'description': 'ventilated newborns / infants / children with healthy lungs and without or corrected congenital heart disease and no intra-/extra-cardiac shunt', 'interventionNames': ['Diagnostic Test: capnography monitoring', 'Diagnostic Test: arterial blood gas']}, {'label': 'mild lung injury', 'description': 'ventilated newborns / infants / children with mild lung injury (OI between 4 and 8)', 'interventionNames': ['Diagnostic Test: capnography monitoring', 'Diagnostic Test: arterial blood gas']}, {'label': 'moderate-severe lung injury', 'description': 'ventilated newborns / infants / children with moderate or severe lung injury (OI above 8)', 'interventionNames': ['Diagnostic Test: capnography monitoring', 'Diagnostic Test: arterial blood gas']}, {'label': 'shunt lesion', 'description': 'ventilated newborns / infants / children with cyanotic heart diseases and therefore existing intra-cardiac or extra- cardiac right-left shunt lesions', 'interventionNames': ['Diagnostic Test: capnography monitoring', 'Diagnostic Test: arterial blood gas']}], 'interventions': [{'name': 'capnography monitoring', 'type': 'DIAGNOSTIC_TEST', 'description': 'routinely used capnography monitoring', 'armGroupLabels': ['mild lung injury', 'moderate-severe lung injury', 'no shunt, no lung injury', 'shunt lesion']}, {'name': 'arterial blood gas', 'type': 'DIAGNOSTIC_TEST', 'description': 'Routinely taken arterial blood gas values', 'armGroupLabels': ['mild lung injury', 'moderate-severe lung injury', 'no shunt, no lung injury', 'shunt lesion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'country': 'Switzerland', 'facility': "University Children's Hospital", 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vincenzo Cannizzaro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior consultant and head of research', 'investigatorFullName': 'Vincenzo Cannizzaro', 'investigatorAffiliation': "University Children's Hospital, Zurich"}}}}