Prediction of Hypotension During Beach Chair Position Using Pleth Variability Index

NCT ID: NCT02527538

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Hypotension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Pleth

Intervention Type DEVICE

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

Interventions

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Pleth

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

Intervention Type DEVICE

Other Intervention Names

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Masimo

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Chongwha Baek

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chongwha Baek, Ph.D.

Role: STUDY_DIRECTOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Locations

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Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yong-Hee Park, M.D.

Role: CONTACT

+82-2-6299-3207

Chongwha Baek, Ph.D.

Role: CONTACT

+82-2-6299-2579

Facility Contacts

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Yong-Hee Park, M.D.

Role: primary

+82-2-6299-3207

Chongwha Baek, Ph.D.

Role: backup

+82-2-6299-2579

References

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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.

Reference Type BACKGROUND
PMID: 25169895 (View on PubMed)

Other Identifiers

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C2013209(1169)

Identifier Type: -

Identifier Source: org_study_id

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