HypotensionNCT07742930
Clinical Validation of Vital-PICASO for Predicting Hypotension Within 24 Hours in General Ward Inpatients
An observational study of Hypotension, run by Huinno AIM at 1 site in South Korea.
Trial summary
This retrospective study evaluated the clinical performance of Vital-PICASO, an artificial intelligence-based biological signal analysis software designed to predict the risk of hypotension within 24 hours using vital-sign data from adult general ward inpatients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypotension
- How many people
- 648 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jul 2025to 13 May 2026
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adult patients aged 19 years or older who were admitted to a general ward at Seoul National University Hospital and had at least 12 hours of electronic medical record data available between January 1, 2023, and May 31, 2025. The retrospective study dataset included patients with an eligible hypotension event occurring in a general ward and patients without hypotension during the selected general ward admission period. Hypotension was defined as systolic blood pressure below 90 mmHg.
Who may be able to join
- General Criteria
- Male or female patient aged 19 years or older at the time the clinical data were recorded
- Electronic medical record data available between January 1, 2023, and May 31, 2025
- Admission to a general ward for at least 12 hours
- Clinical data not previously used in the development of Vital-PICASO
- Hypotension-Positive Group
Show all 17Show fewer
- Hypotension occurred in a general ward
- Hypotension was defined as systolic blood pressure below 90 mmHg
- Vital-sign data were available for up to 72 hours before the hypotension event
- If hypotension occurred within 24 hours after admission or transfer to the general ward, all available vital-sign data recorded before the event were included
- If a patient experienced multiple hypotension events during the data collection period, only the first eligible event was included
- Hypotension-Negative Group
- No hypotension occurred during the selected general ward admission period
- Data were randomly selected from the same general wards as the hypotension-positive group
- Vital-sign data were available from a time interval comparable with the hypotension event reference time or for up to 72 hours after admission to the general ward
- Only one eligible data interval was included per patient
- The data were considered appropriate for inclusion in the hypotension-negative group by the investigator
Who cannot join
- Hypotension occurred outside a general ward
- A do-not-resuscitate order was in effect at the time of data collection
- Pregnancy at the time of data collection or within 3 months after delivery
- The data were considered inappropriate for the study by the principal investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validity of an AI-Based Biological Signal Analysis Software Vital-PICASO for Predicting the Risk of Hypotension Within 24hrs Using Vital Sign (SBP, DBP, HR, RR, BT, SpO2) From General Ward Inpatients; A Retrospective, Single-Center, Single-Arm, Superiority-Confirmatory Clinical Trial
This retrospective study evaluated the clinical performance of Vital-PICASO, an artificial intelligence-based biological signal analysis software designed to predict the risk of hypotension within 24 hours using vital-sign data from adult general ward inpatients.
Electronic medical record data from patients aged 19 years or older who were admitted to a general ward at Seoul National University Hospital were retrospectively reviewed. Hypotension was defined as systolic blood pressure below 90 mmHg. Eligible data were classified as hypotension-positive or hypotension-negative according to predefined reference-standard criteria.
Vital-PICASO was applied to the selected vital-sign datasets, and the software-generated hypotension risk scores were compared with the reference-standard classifications. Predictive performance was evaluated separately using data that included oxygen saturation and data that excluded oxygen saturation. Because the study used previously collected medical records, there was no direct participant contact and the software results were not used to guide patient care.
Read the detailed description
This study was a retrospective, single-center, superiority-confirmatory clinical performance study conducted at Seoul National University Hospital.
Data Source and Study Population
Electronic medical records were reviewed for patients aged 19 years or older who had been admitted to a general ward for at least 12 hours between January 1, 2023, and May 31, 2025. Clinical data previously used in the development of Vital-PICASO were excluded.
The collected variables included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, oxygen saturation when available, and the corresponding measurement times. Additional variables included the occurrence, time, and location of hypotension; month and year of birth; sex; height and weight when available; do-not-resuscitate status; pregnancy status; date of admission to the general ward; clinical department; and the vital-sign data collection period.
Data Selection
Potentially eligible hypotension-positive and hypotension-negative data were identified from the electronic medical record system. To reduce selection bias, candidate data were numbered and randomly selected by an independent statistician using R or SAS software.
Hypotension-positive data were defined as data from patients who experienced hypotension, defined as systolic blood pressure below 90 mmHg, in a general ward. Vital-sign data from up to 72 hours before the first eligible hypotension event were collected. If hypotension occurred within 24 hours after admission or transfer to the general ward, all available vital-sign data recorded before the event were collected, provided that at least 12 hours of data were available.
Hypotension-negative data were obtained from patients who did not experience hypotension during the selected general ward admission. Negative data were randomly selected from the same wards and from time intervals comparable with those of the positive cases. Vital-sign data from up to 72 hours after general ward admission or around the selected reference time point were collected. Only one eligible data interval was selected per patient.
The final study dataset consisted of 648 data cases, including 324 hypotension-positive cases and 324 hypotension-negative cases. Two analysis datasets were evaluated: 168 cases for the analysis including oxygen saturation, consisting of 84 positive and 84 negative cases, and 480 cases for the analysis excluding oxygen saturation, consisting of 240 positive and 240 negative cases. Data cases could be used in both analysis datasets.
Reference Standard Establishment
The initial hypotension-positive or hypotension-negative classification was determined according to the predefined systolic blood pressure criterion. To improve the reliability of the study dataset, a clinician with at least 1 year of clinical experience independently reviewed the data collection reference time point and relevant patient information while blinded to the initial positive or negative classification. The clinician's final classification was used as the reference standard.
Application of the Investigational Device
The medical device operator received vital-sign datasets identified only by screening numbers and was blinded to the reference-standard classification. Each dataset was analyzed using Vital-PICASO to estimate the risk of hypotension within 24 hours. The peak risk score and corresponding time within the analysis interval were recorded.
Statistical Analysis
The software-generated risk scores were compared with the reference-standard classifications. The primary performance measures were the area under the receiver operating characteristic curve for:
- the model including oxygen saturation; and
- the model excluding oxygen saturation.
The AUROC for each model was compared with the prespecified comparator performance value of 0.7847. The performance criterion for each primary outcome was met if the lower bound of the 95% confidence interval for the difference between the Vital-PICASO AUROC and the comparator AUROC was greater than zero. The overall study was considered successful if both primary outcomes met their respective performance criteria.
Secondary performance measures included comparison with the predictive performance of the National Early Warning Score and Modified Early Warning Score, area under the precision-recall curve, precision, recall, F1 score, threshold-specific performance, performance by prediction-time interval, and cumulative-time performance.
Because the study used previously collected electronic medical record data, there was no direct participant contact, additional examination, treatment, or change in clinical care.
- Conditions
- Hypotension
- Keywords
- Hypotension Prediction, Vital-PICASO, Artificial Intelligence, Biological Signal Analysis Software, Vital Signs, General Ward Inpatients, Systolic Blood Pressure, Oxygen Saturation, Early Warning System, Clinical Decision Support
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypotension-Positive Group | Adult general ward inpatient data with an eligible hypotension event, defined as systolic blood pressure below 90 mmHg, occurring in the general ward. Vital-sign data collected for up to 72 hours before the first eligible hypotension event were included. If hypotension occurred within 24 hours after admission or transfer to the general ward, all available vital-sign data recorded before the event were included, provided that at least 12 hours of data were available. | |
| Hypotension-Negative Group | Adult general ward inpatient data from patients who did not experience hypotension during the selected general ward admission. Data were randomly selected from the same general wards as the hypotension-positive group and from a time interval comparable with the hypotension event reference time or from up to 72 hours after admission to the general ward. Only one eligible data interval was selected per patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve for Hypotension Prediction With SpO2
The area under the receiver operating characteristic curve (AUROC) was calculated by comparing the hypotension risk scores generated by Vital-PICASO with the reference-standard classification of hypotension-positive or hypotension-negative.
The analysis included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation as input variables. Hypotension was defined as systolic blood pressure below 90 mmHg.
AUROC ranges from 0 to 1, with a higher value indicating better discrimination. The prespecified success criterion was met if the lower bound of the 95% confidence interval for the difference between the Vital-PICASO AUROC and the comparator AUROC of 0.7847 was greater than 0.
Measured: During the 24-hour period before the hypotension event or corresponding reference time point
Area Under the Receiver Operating Characteristic Curve for Hypotension Prediction Without SpO2
The area under the receiver operating characteristic curve (AUROC) was calculated by comparing the hypotension risk scores generated by Vital-PICASO with the reference-standard classification of hypotension-positive or hypotension-negative.
The analysis included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature as input variables, without oxygen saturation. Hypotension was defined as systolic blood pressure below 90 mmHg.
AUROC ranges from 0 to 1, with a higher value indicating better discrimination. The prespecified success criterion was met if the lower bound of the 95% confidence interval for the difference between the Vital-PICASO AUROC and the comparator AUROC of 0.7847 was greater than 0.
Measured: During the 24-hour period before the hypotension event or corresponding reference time point
Secondary outcomes (7)
Area Under the Precision-Recall Curve for Hypotension Prediction With SpO2
The area under the precision-recall curve (AUPRC) was calculated using the Vital-PICASO risk scores and the reference-standard hypotension classifications when oxygen saturation was included as an input variable.
AUPRC summarizes the relationship between precision and recall across possible classification thresholds. A higher value indicates better predictive performance.
Measured: During the 24-hour period before the hypotension event or corresponding reference time point
Area Under the Precision-Recall Curve for Hypotension Prediction Without SpO2
The area under the precision-recall curve (AUPRC) was calculated using the Vital-PICASO risk scores and the reference-standard hypotension classifications when oxygen saturation was excluded from the input variables.
AUPRC summarizes the relationship between precision and recall across possible classification thresholds. A higher value indicates better predictive performance.
Measured: During the 24-hour period before the hypotension event or corresponding reference time point
Precision, Recall, and F1 Score Across Prespecified Risk-Score Thresholds
Precision, recall, and F1 score were calculated at prespecified Vital-PICASO risk-score thresholds. The analyses were performed separately for the model including oxygen saturation and the model excluding oxygen saturation.
Precision represents the proportion of predicted positive cases that were reference-standard positive. Recall represents the proportion of reference-standard positive cases that were correctly predicted as positive. The F1 score is the harmonic mean of precision and recall.
Each measure ranges from 0 to 1, with a higher value indicating better classification performance.
Measured: During the 24-hour period before the hypotension event or corresponding reference time point
Predictive Performance by Prediction-Time Interval
Vital-PICASO predictive performance was evaluated separately within prespecified time intervals before the hypotension event or corresponding reference time point.
AUROC, AUPRC, and F1 score were calculated for the following intervals:
0 to 1 hour;
1 to 6 hours; 6 to 12 hours; and 12 to 24 hours.
The analyses were conducted separately for the model including oxygen saturation and the model excluding oxygen saturation.
Measured: At 0 to 1, 1 to 6, 6 to 12, and 12 to 24 hours before the hypotension event or corresponding reference time point
Predictive Performance by Cumulative Prediction Window
Vital-PICASO predictive performance was evaluated over cumulative time windows before the hypotension event or corresponding reference time point.
AUROC, AUPRC, and F1 score were calculated for the following cumulative prediction windows:
0 to 1 hour; 0 to 6 hours; 0 to 12 hours; and 0 to 24 hours.
The analyses were conducted separately for the model including oxygen saturation and the model excluding oxygen saturation.
Measured: Up to 24 hours before the hypotension event or corresponding reference time point
Difference Between Vital-PICASO AUROC and the Prespecified NEWS and MEWS Comparator AUROC
The AUROC of Vital-PICASO was compared with the prespecified comparator AUROC of 0.7847 derived from the weighted average predictive performance of the National Early Warning Score, Modified Early Warning Score, and relevant published hypotension-prediction studies.
The difference between the Vital-PICASO AUROC and the comparator AUROC was calculated with a 95% confidence interval. A positive difference favored Vital-PICASO.
The comparison was conducted separately for the model including oxygen saturation and the model excluding oxygen saturation.
Measured: During the 24-hour period before the hypotension event or corresponding reference time point
Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value at the Selected Risk-Score Threshold
Classification performance at the selected Vital-PICASO risk-score threshold was evaluated using sensitivity, specificity, positive predictive value, and negative predictive value.
Sensitivity was defined as the proportion of reference-standard positive cases correctly classified as positive. Specificity was defined as the proportion of reference-standard negative cases correctly classified as negative. Positive predictive value was defined as the proportion of predicted positive cases that were reference-standard positive. Negative predictive value was defined as the proportion of predicted negative cases that were reference-standard negative.
The analyses were conducted separately for the model including oxygen saturation and the model excluding oxygen saturation.
Measured: During the 24-hour period before the hypotension event or corresponding reference time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start21 Jul 2025
- Primary completion1 Apr 2026
- Study completion13 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 648 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huinno AIM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742930
- Sponsor's protocol ID
- HA-PI-02
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validity of an AI-Based Biological Signal Analysis Software Vital-PICASO for Predicting the Risk of Hypotension Within 24hrs Using Vital Sign (SBP, DBP, HR, RR, BT, SpO2) From General Ward Inpatients; A Retrospective, Single-Center, Single-Arm, Superiority-Confirmatory Clinical Trial
- ClinicalTrials.gov ID
- NCT07742930
- Acronym / sponsor ID
- HA-PI-02
- Conditions
- Hypotension
- Keywords
- Hypotension Prediction, Vital-PICASO, Artificial Intelligence, Biological Signal Analysis Software, Vital Signs, General Ward Inpatients, Systolic Blood Pressure, Oxygen Saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 648 participants (actual)
- Lead sponsor
- Huinno AIMIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 13 May 2026 (actual)
- First posted
- 3 Aug 2026 (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 retrospective study evaluated the clinical performance of Vital-PICASO, an artificial intelligence-based biological signal analysis software designed to predict the risk of hypotension within 24 hours using vital-sign data from adult general ward inpatients.
Electronic medical record data from patients aged 19 years or older who were admitted to a general ward at Seoul National University Hospital were retrospectively reviewed. Hypotension was defined as systolic blood pressure below 90 mmHg. Eligible data were classified as hypotension-positive or hypotension-negative according to predefined reference-standard criteria.
Vital-PICASO was applied to the selected vital-sign datasets, and the software-generated hypotension risk scores were compared with the reference-standard classifications. Predictive performance was evaluated separately using data that included oxygen saturation and data that excluded oxygen saturation. Because the study used previously collected medical records, there was no direct participant contact and the software results were not used to guide patient care.
Detailed description
This study was a retrospective, single-center, superiority-confirmatory clinical performance study conducted at Seoul National University Hospital.
Data Source and Study Population
Electronic medical records were reviewed for patients aged 19 years or older who had been admitted to a general ward for at least 12 hours between January 1, 2023, and May 31, 2025. Clinical data previously used in the development of Vital-PICASO were excluded.
The collected variables included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, oxygen saturation when available, and the corresponding measurement times. Additional variables included the occurrence, time, and location of hypotension; month and year of birth; sex; height and weight when available; do-not-resuscitate status; pregnancy status; date of admission to the general ward; clinical department; and the vital-sign data collection period.
Data Selection
Potentially eligible hypotension-positive and hypotension-negative data were identified from the electronic medical record system. To reduce selection bias, candidate data were numbered and randomly selected by an independent statistician using R or SAS software.
Hypotension-positive data were defined as data from patients who experienced hypotension, defined as systolic blood pressure below 90 mmHg, in a general ward. Vital-sign data from up to 72 hours before the first eligible hypotension event were collected. If hypotension occurred within 24 hours after admission or transfer to the general ward, all available vital-sign data recorded before the event were collected, provided that at least 12 hours of data were available.
Hypotension-negative data were obtained from patients who did not experience hypotension during the selected general ward admission. Negative data were randomly selected from the same wards and from time intervals comparable with those of the positive cases. Vital-sign data from up to 72 hours after general ward admission or around the selected reference time point were collected. Only one eligible data interval was selected per patient.
The final study dataset consisted of 648 data cases, including 324 hypotension-positive cases and 324 hypotension-negative cases. Two analysis datasets were evaluated: 168 cases for the analysis including oxygen saturation, consisting of 84 positive and 84 negative cases, and 480 cases for the analysis excluding oxygen saturation, consisting of 240 positive and 240 negative cases. Data cases could be used in both analysis datasets.
Reference Standard Establishment
The initial hypotension-positive or hypotension-negative classification was determined according to the predefined systolic blood pressure criterion. To improve the reliability of the study dataset, a clinician with at least 1 year of clinical experience independently reviewed the data collection reference time point and relevant patient information while blinded to the initial positive or negative classification. The clinician's final classification was used as the reference standard.
Application of the Investigational Device
The medical device operator received vital-sign datasets identified only by screening numbers and was blinded to the reference-standard classification. Each dataset was analyzed using Vital-PICASO to estimate the risk of hypotension within 24 hours. The peak risk score and corresponding time within the analysis interval were recorded.
Statistical Analysis
The software-generated risk scores were compared with the reference-standard classifications. The primary performance measures were the area under the receiver operating characteristic curve for:
- the model including oxygen saturation; and
- the model excluding oxygen saturation.
The AUROC for each model was compared with the prespecified comparator performance value of 0.7847. The performance criterion for each primary outcome was met if the lower bound of the 95% confidence interval for the difference between the Vital-PICASO AUROC and the comparator AUROC was greater than zero. The overall study was considered successful if both primary outcomes met their respective performance criteria.
Secondary performance measures included comparison with the predictive performance of the National Early Warning Score and Modified Early Warning Score, area under the precision-recall curve, precision, recall, F1 score, threshold-specific performance, performance by prediction-time interval, and cumulative-time performance.
Because the study used previously collected electronic medical record data, there was no direct participant contact, additional examination, treatment, or change in clinical care.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypotension-Positive Group | – | –Adult general ward inpatient data with an eligible hypotension event, defined as systolic blood pressure below 90 mmHg, occurring in the general ward. Vital-sign data collected for up to 72 hours before the first eligible hypotension event were included. If hypotension occurred within 24 hours after admission or transfer to the general ward, all available vital-sign data recorded before the event were included, provided that at least 12 hours of data were available. |
| Hypotension-Negative Group | – | –Adult general ward inpatient data from patients who did not experience hypotension during the selected general ward admission. Data were randomly selected from the same general wards as the hypotension-positive group and from a time interval comparable with the hypotension event reference time or from up to 72 hours after admission to the general ward. Only one eligible data interval was selected per patient. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult patients aged 19 years or older who were admitted to a general ward at Seoul National University Hospital and had at least 12 hours of electronic medical record data available between January 1, 2023, and May 31, 2025. The retrospective study dataset included patients with an eligible hypotension event occurring in a general ward and patients without hypotension during the selected general ward admission period. Hypotension was defined as systolic blood pressure below 90 mmHg.
Key inclusion criteria (17 listed)
- General Criteria
- Male or female patient aged 19 years or older at the time the clinical data were recorded
- Electronic medical record data available between January 1, 2023, and May 31, 2025
- Admission to a general ward for at least 12 hours
- Clinical data not previously used in the development of Vital-PICASO
Key exclusion criteria (4 listed)
- Hypotension occurred outside a general ward
- A do-not-resuscitate order was in effect at the time of data collection
- Pregnancy at the time of data collection or within 3 months after delivery
- The data were considered inappropriate for the study by the principal investigator
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
Area Under the Receiver Operating Characteristic Curve for Hypotension Prediction With SpO2
Time frame: During the 24-hour period before the hypotension event or corresponding reference time point
The area under the receiver operating characteristic curve (AUROC) was calculated by comparing the hypotension risk scores generated by Vital-PICASO with the reference-standard classification of hypotension-positive or hypotension-negative. The analysis included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation as input variables. Hypotension was defined as systolic blood pressure below 90 mmHg. AUROC ranges from 0 to 1, with a higher value indicating better discrimination. The prespecified success criterion was met if the lower bound of the 95% confidence interval for the difference between the Vital-PICASO AUROC and the comparator AUROC of 0.7847 was greater than 0.
Area Under the Receiver Operating Characteristic Curve for Hypotension Prediction Without SpO2
Time frame: During the 24-hour period before the hypotension event or corresponding reference time point
The area under the receiver operating characteristic curve (AUROC) was calculated by comparing the hypotension risk scores generated by Vital-PICASO with the reference-standard classification of hypotension-positive or hypotension-negative. The analysis included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature as input variables, without oxygen saturation. Hypotension was defined as systolic blood pressure below 90 mmHg. AUROC ranges from 0 to 1, with a higher value indicating better discrimination. The prespecified success criterion was met if the lower bound of the 95% confidence interval for the difference between the Vital-PICASO AUROC and the comparator AUROC of 0.7847 was greater than 0.
7 secondary outcomes
Area Under the Precision-Recall Curve for Hypotension Prediction With SpO2
Time frame: During the 24-hour period before the hypotension event or corresponding reference time point
Area Under the Precision-Recall Curve for Hypotension Prediction Without SpO2
Time frame: During the 24-hour period before the hypotension event or corresponding reference time point
Precision, Recall, and F1 Score Across Prespecified Risk-Score Thresholds
Time frame: During the 24-hour period before the hypotension event or corresponding reference time point
Predictive Performance by Prediction-Time Interval
Time frame: At 0 to 1, 1 to 6, 6 to 12, and 12 to 24 hours before the hypotension event or corresponding reference time point
Predictive Performance by Cumulative Prediction Window
Time frame: Up to 24 hours before the hypotension event or corresponding reference time point
Difference Between Vital-PICASO AUROC and the Prespecified NEWS and MEWS Comparator AUROC
Time frame: During the 24-hour period before the hypotension event or corresponding reference time point
Sensitivity, Specificity, Positive Predictive Value, and Negative Predictive Value at the Selected Risk-Score Threshold
Time frame: During the 24-hour period before the hypotension event or corresponding reference time point
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 3 Aug 2026.
- Individual participant dataSharing planned: No
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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 Hypotension, run by Huinno AIM at 1 site in South Korea.
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 17 inclusion and 4 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 3 Aug 2026. 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 South Korea. 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?
Area Under the Receiver Operating Characteristic Curve for Hypotension Prediction With SpO2 (time frame: During the 24-hour period before the hypotension event or corresponding reference time point). The study lists 2 primary outcomes in all. 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 3 Aug 2026.