Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-06 @ 2:00 PM
Study NCT ID:
NCT05341258
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2022-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arterial and End-Tidal CO2 Gradient as a Mortality Predictor in Critical Care Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'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': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-22', 'studyFirstSubmitDate': '2022-04-17', 'studyFirstSubmitQcDate': '2022-04-17', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6 months', 'description': 'Evaluation of correlation between PaCO2 and ETCO2 gradient difference and mortality in intubated critical care patients and mortality rates'}], 'secondaryOutcomes': [{'measure': 'ICU Length of Stay', 'timeFrame': '6 months', 'description': 'Days patients treated at ICU'}, {'measure': 'Ventilator Free Days', 'timeFrame': '6 months', 'description': 'Days during which the patient was mechanically ventilated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'Ventilation Perfusion Mismatch', 'Shock', 'Pulmonary Embolism', 'Trauma', 'Copd']}, 'descriptionModule': {'briefSummary': "Scoring systems (SOFA, APACHE-II etc.) are used to estimate the mortality rates of patients treated in the intensive care unit. . In the scoring systems used, the disfunction level of the organs of the patients is measured. Blood gas analysis is routinely performed in patients whom intubated in the intensive care unit and receiving mechanical ventilation support, and the patient's treatment is optimized according to the results of the examination. The patient's mechanical ventilation settings are regulated by analyzing the Partial Arterial Carbondioxide (paCO2) value in the patient's blood gas result. The difference between the paCO2 value in the blood gas and the End-tidal Carbondioxide (EtCO2) value measured in the mechanical ventilator is 3-5mmHg in normal healthy people, while this difference is seen more in critical care patients. In critically ill patients in the intensive care unit, there is a greater increase in the difference between paCO2 and ETCO2 in cases where mortality is high, such as global perfusion disorder, shock situations, and massive pulmonary embolism, etc. In this study, it was planned to investigate the use of the difference between the paCO2 value in the blood gas taken from the patient and the ETCO2 value measured in the mechanical ventilator to predict the mortality rate of the patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critical Care Patients intubated in last 24 hours.\n\nExclusion Criteria:\n\n* Patients younger than 18 years old.'}, 'identificationModule': {'nctId': 'NCT05341258', 'briefTitle': 'Arterial and End-Tidal CO2 Gradient as a Mortality Predictor in Critical Care Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gaziosmanpasa Research and Education Hospital'}, 'officialTitle': 'Arterial and End-Tidal CO2 Gradient as a Mortality Predictor in Critical Care Patients', 'orgStudyIdInfo': {'id': '3751'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Critical Care Patients whom intubated last 24 hours', 'description': 'Critical Care Patients whom intubated last 24 hours', 'interventionNames': ['Diagnostic Test: EtCO2', 'Diagnostic Test: PaCO2']}], 'interventions': [{'name': 'EtCO2', 'type': 'DIAGNOSTIC_TEST', 'description': 'EtCO2', 'armGroupLabels': ['Critical Care Patients whom intubated last 24 hours']}, {'name': 'PaCO2', 'type': 'DIAGNOSTIC_TEST', 'description': 'PaCO2', 'armGroupLabels': ['Critical Care Patients whom intubated last 24 hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34255', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziosmanpasa Training Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ulku Aygen Turkmen, Proffessor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director of Anesthesiology and Reanimation Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaziosmanpasa Research and Education Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}