HypotensionNCT04850092
Dynamic Arterial Elastance to Predict Postural Change Induced Hypotension
An observational study of Hypotension, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
During general anesthesia, hypotension might occur during positional change. It is reported that hypotension after positional change from supine to prone is mainly caused by the decrease in preload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Positional change from supine to prone
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Dec 2021to 15 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are scheduled for spine surgery and need positional change from supine to prone positioin.
Who may be able to join
- Patients planned for invasive arterial catheter insertion, undergoing elective spine surgery in prone position under general anesthesia
Who cannot join
- arrythmia
- pulmonary disease
- increased intracranial pressure
- decreased cardiac function (ejection fraction < 50%)
- obesity (body mass index > 40)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on Dynamic Arterial Elastance as a Predictor of Hypotension Caused by the Positional Change From Supine to Prone (SuProne Study).
During general anesthesia, hypotension might occur during positional change. It is reported that hypotension after positional change from supine to prone is mainly caused by the decrease in preload. The investigators aimed to investigate whether dynamic arterial elastance might predict hypotension associated with positional change from supine to prone.
- Conditions
- Hypotension
- Being tested
- Positional change from supine to prone
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positional change from supine to proneOther
Patient is turned from supine to prone position for spine surgery
| Study group | Role | What they receive |
|---|---|---|
| Non-hypotensive | Mean blood pressure is maintained after positional change from supine to prone. Receives: Other: Positional change from supine to prone | |
| Hypotensive | Mean blood pressure decrease < 20% after positional change from supine to prone. Receives: Other: Positional change from supine to prone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic arterial elastance before positional change
Dynamic arterial elastance, defined as the ratio of pulse pressure variance/stroke volume variance will be recorded 1 minute before positional change
Measured: 1 minute before positional change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start15 Dec 2021
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eunah Cho, MD, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850092
- Sponsor's protocol ID
- KBSMC 2021-04-038
- Status last verified
- Sep 2022
- First submitted
- 14 Apr 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Dynamic Arterial Elastance as a Predictor of Hypotension Caused by the Positional Change From Supine to Prone (SuProne Study).
- ClinicalTrials.gov ID
- NCT04850092
- Acronym / sponsor ID
- KBSMC 2021-04-038
- Conditions
- Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 20 Apr 2021 (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.
During general anesthesia, hypotension might occur during positional change. It is reported that hypotension after positional change from supine to prone is mainly caused by the decrease in preload. The investigators aimed to investigate whether dynamic arterial elastance might predict hypotension associated with positional change from supine to prone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-hypotensive | – | Other: Positional change from supine to proneMean blood pressure is maintained after positional change from supine to prone. |
| Hypotensive | – | Other: Positional change from supine to proneMean blood pressure decrease < 20% after positional change from supine to prone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are scheduled for spine surgery and need positional change from supine to prone positioin.
Key inclusion criteria (1 listed)
- Patients planned for invasive arterial catheter insertion, undergoing elective spine surgery in prone position under general anesthesia
Key exclusion criteria (5 listed)
- arrythmia
- pulmonary disease
- increased intracranial pressure
- decreased cardiac function (ejection fraction < 50%)
- obesity (body mass index > 40)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positional change from supine to pronePatient is turned from supine to prone position for spine surgery | Other | Hypotensive, Non-hypotensive |
Primary outcome
Dynamic arterial elastance before positional change
Time frame: 1 minute before positional change
Dynamic arterial elastance, defined as the ratio of pulse pressure variance/stroke volume variance will be recorded 1 minute before positional change
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 23 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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 Kangbuk Samsung Hospital 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 1 inclusion and 5 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 23 Sep 2022. 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?
Dynamic arterial elastance before positional change (time frame: 1 minute before positional change). 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 23 Sep 2022.