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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03393559
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.9
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Hypotension; Cerebral Ischemia; Shoulder Disease	Procedure: leg elevation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized controlled trialrandomized controlled trial
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Leg Elevation on the Prevention of Intraoperative Hypotension During Shoulder Surgery in the Beach Chair Position
• Actual Study Start Date: Jan 24, 2018
• Actual Primary Completion Date: Dec 11, 2019
• Actual Study Completion Date: Dec 21, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Incidence of intraoperative hypotension [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

Secondary Outcome Measures

1. Incidence of intraoperative cerebral desaturation [From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)]

   Cerebral oxygen saturation < 80% of baseline longer than 30 seconds

2. Total amounts of administered inotropic agents [From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)]

   Total amounts of administered inotropic agents after the Beach-chair positioning

3. Systolic blood pressure [before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning]

   Systolic blood pressure in mmHg at multiple time-points

4. Heart rate [before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning]

   Heart rate in bpm at multiple time-points

5. Peripheral oxygen saturation [before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning]

   Peripheral oxygen saturation in percentage at multiple time-points

6. Cerebral oxygen saturation [before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning]

   Cerebral oxygen saturation in percentage at multiple time-points

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jin-Tae Kim, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jin-Tae Kim, Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03393559
• Other Study ID Numbers: H-1712-023-903
• First Posted: Jan 8, 2018
• Last Update Posted: Dec 27, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Ischemia; Cerebral Infarction; Hypotension; Ischemia

Study Results

No Results Posted as of Dec 27, 2019