Effect of Leg Elevation on Prevention of Intraoperative Hypotension During Beach Chair Position

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Ischemia; Intraoperative Hypotension; Shoulder Disease
• Intervention / Treatment: Procedure: leg elevation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients undergoing shoulder surgery in the beach chair position

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group L; leg elevation during the beach chair position	Procedure: leg elevation; 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.
No Intervention: Group C; Patients' leg will be straightened without any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative hypotension	Mean blood pressure < 60 mmHg or systolic blood pressure < 80% of baseline	From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative cerebral desaturation	Cerebral oxygen saturation < 80% of baseline longer than 30 seconds	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	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	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	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	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	before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2018
• Primary Completion (Actual): December 11, 2019
• Study Completion (Actual): December 21, 2019

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): December 27, 2019
• Last Update Submitted That Met QC Criteria: December 26, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Stroke; Brain Infarction; Brain Ischemia; Ischemia; Cerebral Infarction; Hypotension
• Other Study ID Numbers: H-1712-023-903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: IPD will be made available after article publication, for 3 years from the study completion.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No