ArdsMNONCT06109168
Correlation of SpO2/FIO2 Ratio With PaO2/FIO2 Ratio in ARDS Patients in the ICU of H. Adam Malik Hospital
An observational study of Ards, run by RS H Adam Malik at 1 site in Indonesia.
Trial summary
This study to apprehend the relation of SpO2/FiO2 to PaO2/FiO2 in ARDS patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ards
- How many people
- 29 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2023to 1 Sep 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Intubated patients in ICU
Who may be able to join
- ARDS patient
- intubarted patient
Who cannot join
- Cardiac congenital disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of SpO2/FIO2 Ration With PaO2/FIO2 Ratio in Acute Respiratory Distress Syndrome (ARDS) Patients in the ICU of H. Adam Malik Hospital
This study to apprehend the relation of SpO2/FiO2 to PaO2/FiO2 in ARDS patients.
Read the detailed 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.
- Conditions
- Ards
- Medical subject headings
- Acute Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: June - August 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Jun 2023
- Primary completion31 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArdsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- RS H Adam Malik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agus pramono, RS H Adam Malik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109168
- Sponsor's protocol ID
- 536/KEPK/USU/2023
- Acronym
- MNO
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of SpO2/FIO2 Ration With PaO2/FIO2 Ratio in Acute Respiratory Distress Syndrome (ARDS) Patients in the ICU of H. Adam Malik Hospital
- ClinicalTrials.gov ID
- NCT06109168
- Acronym / sponsor ID
- MNO / 536/KEPK/USU/2023
- Conditions
- Ards
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- RS H Adam MalikUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study to apprehend the relation of SpO2/FiO2 to PaO2/FiO2 in ARDS patients.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Intubated patients in ICU
Key inclusion criteria (2 listed)
- ARDS patient
- intubarted patient
Key exclusion criteria (1 listed)
- Cardiac congenital disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of SpO2/FIO2 Ratio with PaO2/FIO2 Ratio in Acute Respiratory Distress Syndrome (ARDS) Patiens in the ICU of H. Adam Malik Hospital
Time frame: June - August 2023
ICU patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ards, run by RS H Adam Malik at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: June - August 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.