Prediction of Hypotension During Beach Chair Position Using Pleth Variability Index

• Conditions: Hypotension
• Interventions: Device: Pleth

• Registration Number: NCT02527538
• Lead Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Brief Summary

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.

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-28
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-19
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-28
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pleth	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital; 🇰🇷 Seoul, Korea, Republic of