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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06109168
Other study ID # 536/KEPK/USU/2023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date September 1, 2023

Study information

Verified date November 2023
Source RS H Adam Malik
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study to apprehend the relation of SpO2/FiO2 to PaO2/FiO2 in ARDS patients.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date September 1, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - ARDS patient - intubarted patient Exclusion Criteria: - Cardiac congenital disorder

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Indonesia RSUP H. ADam Malik Medan SUmatera UTara

Sponsors (1)

Lead Sponsor Collaborator
RS H Adam Malik

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of SpO2/FIO2 Ratio with PaO2/FIO2 Ratio in Acute Respiratory Distress Syndrome (ARDS) Patiens in the ICU of H. Adam Malik Hospital ICU patients June - August 2023
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