An interventional study of leg elevation in Intraoperative Hypotension, Cerebral Ischemia and Shoulder Disease, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-12-27.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention
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.
217 studies on the registry are indexed under Brain Ischemia; 42 are open to participants now.
This study's enrollment of 50 is below the median of 73 across 140 interventional studies indexed under Brain Ischemia.
Browse Brain Ischemia studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
leg elevation during the beach chair position
Procedure: leg elevation
Patients' leg will be straightened without any intervention.
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.
Incidence of intraoperative hypotension
Mean blood pressure \< 60 mmHg or systolic blood pressure \< 80% of baseline
Time frame: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)
Incidence of intraoperative cerebral desaturation
Cerebral oxygen saturation \< 80% of baseline longer than 30 seconds
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
Total amounts of administered inotropic agents after the Beach-chair positioning
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available after article publication, for 3 years from the study completion.
Access criteria: Proposals should be directed to the corresponding author and will be reviewed by the study group. Only requests that have a methodologically sound proposal and whose proposed use of the data has been approved by the independent review committee will be considered.
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Dec 2019, 22 months.
Of 43 interventional studies with no phase under Brain Ischemia, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's 22 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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