Intraoperative HypotensionNCT03393559
Effect of Leg Elevation on Prevention of Intraoperative Hypotension During Beach Chair Position
A study testing leg elevation in people with Intraoperative Hypotension and Cerebral Ischemia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to evaluate the effect of leg elevation on the prevention of intraoperative hypotension during shoulder surgery in the Beach-chair position. patients undergoing shoulder surgery in the Beach-chair position will be randomly assigned to Group L (with leg elevation) or Group C (no intervention). Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Intraoperative Hypotension, Cerebral Ischemia, Shoulder Disease
- What is being tested?
- leg elevation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jan 2018to 21 Dec 2019
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients undergoing shoulder surgery in the beach chair position
Who cannot join
- Patients with myocardial infarction
- Patients with pacemaker
- Patients with cerebrovascular disease
- patients with arteriovenous fistula at the opposite arm
- Patients with autonomic nerve disorders
- Patients with hip or knee joint disorder limiting hip or knee flexion
- BMI > 30 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Leg Elevation on the Prevention of Intraoperative Hypotension During Shoulder Surgery in the Beach Chair Position
The aim of this study is to evaluate the effect of leg elevation on the prevention of intraoperative hypotension during shoulder surgery in the Beach-chair position. patients undergoing shoulder surgery in the Beach-chair position will be randomly assigned to Group L (with leg elevation) or Group C (no intervention). The primary outcome is the incidence of intraoperative hypotension (mean blood pressure < 60mmHg or systolic blood pressure < 80% of baseline). Secondary outcomes are the incidence of intraoperative cerebral desaturation (cerebral oxygen saturation < 80% of baseline, longer than 30 seconds), total amounts of administered inotropic agents, and systolic blood pressure, heart rate, and cerebral oxygen saturation at various time points.
- Being tested
- leg elevation
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leg elevationProcedure or surgery
Patients' leg will be raised by a pillow under both legs and the hip and knee joints will be flexed 45 degrees to position both knees at the heart level.
| Study group | Role | What they receive |
|---|---|---|
| Group L | Experimental | leg elevation during the beach chair position Receives: Procedure: leg elevation |
| Group C | No intervention | Patients' leg will be straightened without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative hypotension
Mean blood pressure < 60 mmHg or systolic blood pressure < 80% of baseline
Measured: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)
Secondary outcomes (6)
Incidence of intraoperative cerebral desaturation
Cerebral oxygen saturation < 80% of baseline longer than 30 seconds
Measured: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)
Total amounts of administered inotropic agents
Total amounts of administered inotropic agents after the Beach-chair positioning
Measured: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)
Systolic blood pressure
Systolic blood pressure in mmHg at multiple time-points
Measured: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
Heart rate
Heart rate in bpm at multiple time-points
Measured: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
Peripheral oxygen saturation
Peripheral oxygen saturation in percentage at multiple time-points
Measured: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
Cerebral oxygen saturation
Cerebral oxygen saturation in percentage at multiple time-points
Measured: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start24 Jan 2018
- Primary completion11 Dec 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393559
- Sponsor's protocol ID
- H-1712-023-903
- Status last verified
- Dec 2019
- First submitted
- 26 Dec 2017
- Last updated
- 27 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Nam S, Yoo S, Kim SH, Park SK, Lim YJ, Kim JT. Limited effect of leg elevation in preventing intraoperative hypotension during total shoulder arthroplasty in the beach chair position: a randomized controlled trial. BMC Anesthesiol. 2025 Oct 1;25(1):472. doi: 10.1186/s12871-025-03299-1.
PubMed 41034767
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Leg Elevation on the Prevention of Intraoperative Hypotension During Shoulder Surgery in the Beach Chair Position
- ClinicalTrials.gov ID
- NCT03393559
- Acronym / sponsor ID
- H-1712-023-903
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 8 Jan 2018 (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.
The aim of this study is to evaluate the effect of leg elevation on the prevention of intraoperative hypotension during shoulder surgery in the Beach-chair position. patients undergoing shoulder surgery in the Beach-chair position will be randomly assigned to Group L (with leg elevation) or Group C (no intervention). The primary outcome is the incidence of intraoperative hypotension (mean blood pressure < 60mmHg or systolic blood pressure < 80% of baseline). Secondary outcomes are the incidence of intraoperative cerebral desaturation (cerebral oxygen saturation < 80% of baseline, longer than 30 seconds), total amounts of administered inotropic agents, and systolic blood pressure, heart rate, and cerebral oxygen saturation at various time points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group L | Experimental | Procedure: leg elevationleg elevation during the beach chair position |
| Group C | No intervention | –Patients' leg will be straightened without any intervention. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients undergoing shoulder surgery in the beach chair position
Key exclusion criteria (7 listed)
- Patients with myocardial infarction
- Patients with pacemaker
- Patients with cerebrovascular disease
- patients with arteriovenous fistula at the opposite arm
- Patients with autonomic nerve disorders
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 |
|---|---|---|
| leg elevationPatients' leg will be raised by a pillow under both legs and the hip and knee joints will be flexed 45 degrees to position both knees at the heart level. | Procedure or surgery | Group L |
Primary outcome
Incidence of intraoperative hypotension
Time frame: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)
Mean blood pressure < 60 mmHg or systolic blood pressure < 80% of baseline
6 secondary outcomes
Incidence of intraoperative cerebral desaturation
Time frame: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)
Total amounts of administered inotropic agents
Time frame: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)
Systolic blood pressure
Time frame: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
Heart rate
Time frame: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
Peripheral oxygen saturation
Time frame: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
Cerebral oxygen saturation
Time frame: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
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 27 Dec 2019.
- Derived from this study: PubMed 41034767Nam S, Yoo S, Kim SH, Park SK, Lim YJ, Kim JT. Limited effect of leg elevation in preventing intraoperative hypotension during total shoulder arthroplasty in the beach chair position: a randomized controlled trial. BMC Anesthesiol. 2025 Oct 1;25(1):472. doi: 10.1186/s12871-025-03299-1.
- Individual participant dataSharing planned: Yes
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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.
Jin-Tae Kim, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leg elevation in people with Intraoperative Hypotension and Cerebral Ischemia, run by Seoul National University 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 7 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 27 Dec 2019. 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?
Incidence of intraoperative hypotension (time frame: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393559, which also lists 1 linked publication.
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 27 Dec 2019.