Prediction of Hypotension During Beach Chair Position Using Pleth Variability Index

Pleth Variability Index Predicts Hypotension in Beach Chair Position in Mechanically Ventilated Adults During General Anesthesia

The beach chair position for shoulder operation induces hypotension during general anesthesia. Hypotension is induced by decreased preload and contractility due to anesthesia. Masimo is a pulse oximetry which shows pleth variability index noninvasively. The pleth variability may predict the hypotension during beach chair position.

Study Overview

• Status: Unknown
• Conditions: Hypotension
• Intervention / Treatment: Device: Pleth

Detailed Description

The beach chair position for shoulder operation induces hypotension during general anesthesia. Hypotension is induced by decreased preload and contractility due to anesthesia. Masimo is a pulse oximetry which shows pleth variability index noninvasively. The investigators put the masimo probe before general anesthesia and recorded the values before and after beach chair position, The values include arterial pressure, heart rate, blood pressure, perfusion index, pleth variability index.

The primary end point was the predictive value and threshold or pleth variability index for hypotension induced by the beach chair position. The occurrence of hypotension was counted by using vasopressor. The use of vasopressor was performed when mean blood pressure less than 65 mmHg or 20% of baseline.

The investigators planned to recruit 57 patients.

• Study Type: Observational
• Enrollment (Anticipated): 57

Contacts and Locations

• Study Contact: Name: Yong-Hee Park, M.D.; Phone Number: +82-2-6299-3207; Email: dada822@naver.com
• Study Contact Backup: Name: Chongwha Baek, Ph.D.; Phone Number: +82-2-6299-2579; Email: nbjhwa@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital
    • Contact: Yong-Hee Park, M.D.; Phone Number: +82-2-6299-3207; Email: dada822@naver.com
    • Contact: Chongwha Baek, Ph.D.; Phone Number: +82-2-6299-2579

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

age between 20 and 70 years who is planning to undergoing elective shoulder surgery under general anesthesia

Description

Inclusion Criteria:

• elective shoulder surgery under general anesthesia

Exclusion Criteria:

• right heart failure
• morbid obesity (BMI > 30)
• arrhythmia on preoperative electrocardiography
• pulmonary hypertension
• peripheral vascular disease or pulmonary disease
• pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pleth; The masimo probe is attached on the index fingertip and cover with black cover in all patients. Record the pleth variability index and blood pressure	Device: Pleth; apply the masimo probe on index fingertip and record the pleth variability and blood pressure during beach chair position; Other Names: Masimo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of hypotension defined as mean blood pressure less than 65 mmHg or 20% of baseline	hypotension occurs or not after beach chair position and hypotension was defined as mean blood pressure less than 65 mmHg or 20% of baseline	10 minutes after beach chair position

Collaborators and Investigators

• Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
• Investigators: Study Director: Chongwha Baek, Ph.D., Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Publications and helpful links

General Publications

• Siswojo AS, Wong DM, Phan TD, Kluger R. Pleth variability index predicts fluid responsiveness in mechanically ventilated adults during general anesthesia for noncardiac surgery. J Cardiothorac Vasc Anesth. 2014 Dec;28(6):1505-9. doi: 10.1053/j.jvca.2014.04.010. Epub 2014 Aug 29.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: August 17, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: C2013209(1169)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided