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

Primary Purpose

Intraoperative Hypotension, Cerebral Ischemia, Shoulder Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
leg elevation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Hypotension

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group L

Group C

Arm Description

leg elevation during the beach chair position

Patients' leg will be straightened without any intervention.

Outcomes

Primary Outcome Measures

Incidence of intraoperative hypotension
Mean blood pressure < 60 mmHg or systolic blood pressure < 80% of baseline

Secondary Outcome Measures

Incidence of intraoperative cerebral desaturation
Cerebral oxygen saturation < 80% of baseline longer than 30 seconds
Total amounts of administered inotropic agents
Total amounts of administered inotropic agents after the Beach-chair positioning
Systolic blood pressure
Systolic blood pressure in mmHg at multiple time-points
Heart rate
Heart rate in bpm at multiple time-points
Peripheral oxygen saturation
Peripheral oxygen saturation in percentage at multiple time-points
Cerebral oxygen saturation
Cerebral oxygen saturation in percentage at multiple time-points

Full Information

First Posted
December 26, 2017
Last Updated
December 26, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03393559
Brief Title
Effect of Leg Elevation on Prevention of Intraoperative Hypotension During Beach Chair Position
Official Title
The Effect of Leg Elevation on the Prevention of Intraoperative Hypotension During Shoulder Surgery in the Beach Chair Position
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 24, 2018 (Actual)
Primary Completion Date
December 11, 2019 (Actual)
Study Completion Date
December 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Hypotension, Cerebral Ischemia, Shoulder Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group L
Arm Type
Experimental
Arm Description
leg elevation during the beach chair position
Arm Title
Group C
Arm Type
No Intervention
Arm Description
Patients' leg will be straightened without any intervention.
Intervention Type
Procedure
Intervention Name(s)
leg elevation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of intraoperative hypotension
Description
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)
Secondary Outcome Measure Information:
Title
Incidence of intraoperative cerebral desaturation
Description
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)
Title
Total amounts of administered inotropic agents
Description
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)
Title
Systolic blood pressure
Description
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
Title
Heart rate
Description
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
Title
Peripheral oxygen saturation
Description
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
Title
Cerebral oxygen saturation
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share 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.

Learn more about this trial

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

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