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
1 other identifier
observational
57
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 28, 2015
CompletedFirst Posted
Study publicly available on registry
August 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJanuary 28, 2016
August 1, 2015
1 year
July 28, 2015
January 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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
Interventions
apply the masimo probe on index fingertip and record the pleth variability and blood pressure during beach chair position
Eligibility Criteria
age between 20 and 70 years who is planning to undergoing elective shoulder surgery under general anesthesia
You may qualify if:
- elective shoulder surgery under general anesthesia
You may not qualify if:
- right heart failure
- morbid obesity (BMI \> 30)
- arrhythmia on preoperative electrocardiography
- pulmonary hypertension
- peripheral vascular disease or pulmonary disease
- pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 25169895BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chongwha Baek, Ph.D.
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 28, 2015
First Posted
August 19, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
January 28, 2016
Record last verified: 2015-08