Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-05 @ 9:30 PM
Study NCT ID:
NCT06109168
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2023-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation of SpO2/FIO2 Ratio With PaO2/FIO2 Ratio in ARDS Patients in the ICU of H. Adam Malik Hospital
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood Gas Analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-11', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of SpO2/FIO2 Ratio with PaO2/FIO2 Ratio in Acute Respiratory Distress Syndrome (ARDS) Patiens in the ICU of H. Adam Malik Hospital', 'timeFrame': 'June - August 2023', 'description': 'ICU patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ards']}, 'descriptionModule': {'briefSummary': 'This study to apprehend the relation of SpO2/FiO2 to PaO2/FiO2 in ARDS patients.', 'detailedDescription': 'Acute Respiratory Distress Syndrome (ARDS) is a life-threatening condition that requires immediate treatment. The measurement of the PaO2/FiO2 (P/F) ratio is the main choice for assessing the severity of ARDS with an invasive method that requires arterial blood gas (ABG) analysis. This study was conducted to determine the relationship between the SpO2/FiO2 ratio and the PaO2/FiO2 ratio in ARDS patients at HAM General Hospital. This observational study used a cross-sectional research method with the total sample of 29 intubated ICU patients diagnosed with ARDS. Patients with congestive heart failure, anemia, and systolic blood pressure \\<90 mmHg were excluded from the study. The results of this study showed a positive correlation between the PaO2/FiO2 and SpO2/FiO2 ratios with a correlation coefficient of 0.955 and a p-value of 0.001. There was a relationship between the S/F ratio and the P/F ratio in assessing the severity of ARDS with a p-value of \\<0.05. This study shows that the SpO2/FiO2 (S/F) ratio has a good correlation with the PaO2/FiO2 (P/F) ratio in patients with ARDS, so it can be used as a predictor of ARDS and can be beneficial in clinical practice. It should be noted that the SpO2/FiO2 ratio has several factors that can affect its accuracy, so careful assessment is needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Intubated patients in ICU', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ARDS patient\n* intubarted patient\n\nExclusion Criteria:\n\n* Cardiac congenital disorder'}, 'identificationModule': {'nctId': 'NCT06109168', 'acronym': 'MNO', 'briefTitle': 'Correlation of SpO2/FIO2 Ratio With PaO2/FIO2 Ratio in ARDS Patients in the ICU of H. Adam Malik Hospital', 'organization': {'class': 'OTHER', 'fullName': 'RS H Adam Malik'}, 'officialTitle': 'Correlation of SpO2/FIO2 Ration With PaO2/FIO2 Ratio in Acute Respiratory Distress Syndrome (ARDS) Patients in the ICU of H. Adam Malik Hospital', 'orgStudyIdInfo': {'id': '536/KEPK/USU/2023'}}, 'contactsLocationsModule': {'locations': [{'zip': '20222', 'city': 'Medan', 'state': 'North Sumatra', 'country': 'Indonesia', 'facility': 'RSUP H. ADam Malik', 'geoPoint': {'lat': 3.58333, 'lon': 98.66667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RS H Adam Malik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Department of Anesthesiology and Emergency Medicine of Medical Faculty USU', 'investigatorFullName': 'Agus pramono', 'investigatorAffiliation': 'RS H Adam Malik'}}}}