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Peripheral Venous Pressure Variation, Pulse Pressure Variation and Pleth Variability Index for Fluid Responsiveness

NCT ID: NCT06733389

Last Updated: 2024-12-17

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

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-28

Study Completion Date

2026-11-28

Brief Summary

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Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy in patients receiving mechanical ventilation. PPV, which measures changes in arterial pressure, requires arterial puncture, which is invasive, and PVI, which detects subtle changes in oxygen saturation, requires an expensive, commercial monitoring equipment. In this study, we aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy. In addition, the investigators aimed to confirm the superiority of the indicators by comparing them with the responsiveness to fluid therapy of the PPV and PVI.

Detailed Description

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Pulse pressure variation (PPV) and pleth variability index (PVI) are widely used in clinical practice as indicators of the responsiveness to fluid therapy. The investigators aimed to measure peripheral venous pressure variation using less invasive waveform variation in peripheral veins and to determine whether this indicator can be clinically used to predict the responsiveness to fluid therapy.

Conditions

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Pulse Pressure Variation Stroke Volume Variation Pleth Variability Index

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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peripheral waveform collection group

1. Peripheral Venous Pressure Variation
2. Pulse Pressure Variation
3. Pleth Variability Index

peripheral waveform collection

Intervention Type OTHER

The peripheral venous pressure is collected by connecting a pressure transducer that is currently in use to the central venous line. In addition, pulse pressure variation and stroke volume variation that can be obtained from the arterial catheter. In addition, the pleth variability index is collected through the oxygen saturation monitoring. This extracts the medical records and bio-signal information of the subjects registered through the previously approved 'Establishment of a Bio-signal and Clinical Information Registry for the Development of Patient Monitoring Algorithms' (B-2202-738-401).

Interventions

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peripheral waveform collection

The peripheral venous pressure is collected by connecting a pressure transducer that is currently in use to the central venous line. In addition, pulse pressure variation and stroke volume variation that can be obtained from the arterial catheter. In addition, the pleth variability index is collected through the oxygen saturation monitoring. This extracts the medical records and bio-signal information of the subjects registered through the previously approved 'Establishment of a Bio-signal and Clinical Information Registry for the Development of Patient Monitoring Algorithms' (B-2202-738-401).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients voluntarily agreed and signed the written informed consent form before participating in the study
* Adults aged 19 years or older
* American Society of Anesthesiologists physical class (ASA) 1-3
* Patients scheduled for elective hepatectomy under general anesthesia
* Patients who require arterial pressure monitoring and additional peripheral venous access for routine anesthesia preparation
* Non-smokers with normal pulmonary function

Exclusion Criteria

* Patients with abnormal findings on electrocardiogram before surgery
* Patients who cannot undergo peripheral venous puncture
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Park InSun

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Insun Park

Role: PRINCIPAL_INVESTIGATOR

assistant professor

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyunggi-do, South Korea

Site Status

Countries

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South Korea

Central Contacts

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Insun Park, M.D./Ph.D.

Role: CONTACT

Phone: 823178777499

Email: [email protected]

Other Identifiers

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B-2412-941-301

Identifier Type: -

Identifier Source: org_study_id