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Status unknownNCT02527538Updated Jan 28, 2016

Prediction of Hypotension During Beach Chair Position Using Pleth Variability Index

An observational study in Hypotension, sponsored by Chung-Ang University Hosptial, Chung-Ang University College of Medicine. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-01-28.

Sponsored by Chung-Ang University Hosptial, Chung-Ang University College of Medicine · Observational

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
57
Ages
20 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hypotension

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03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's planned enrollment of 57 is below the median of 84 across 294 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • elective shoulder surgery under general anesthesia

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
57 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DevicePleth

    apply the masimo probe on index fingertip and record the pleth variability and blood pressure during beach chair position

    Also known as: Masimo

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What researchers measure

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

    Time frame: 10 minutes after beach chair position

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Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital
    Seoul, Korea, Republic of
    • Yong-Hee Park, M.D. · Contact · dada822@naver.com · +82-2-6299-3207
    • Chongwha Baek, Ph.D. · Contact · +82-2-6299-2579
    Recruiting
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References and documents

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. PubMed 25169895 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02527538
Lead sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Responsible party
Chongwha Baek (Professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine) — Principal investigator
First posted
Aug 19, 2015
Start date
Jun 2015
Primary completion
Jun 2016 (estimated)
Completion
Jun 2016 (estimated)
Last update
Jan 28, 2016

Study contacts

Yong-Hee Park, M.D.
Contact
dada822@naver.com
+82-2-6299-3207
Chongwha Baek, Ph.D.
Contact
nbjhwa@naver.com
+82-2-6299-2579
Chongwha Baek, Ph.D.
study director · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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