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Evaluation of the Changes of Pleth Variability Index During Preoxygenation for Predicting Hypotension

Primary Purpose

Hypotension on Induction

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Preoxygenation
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypotension on Induction focused on measuring Hypovolemia, Pulse Wave Analysis, Hypotension, Anesthesia, General

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients undergoing elective surgery under general anesthesia

Exclusion Criteria:

  • (1) American Society of Anesthesiologists (ASA) physical status classification III or higher (2) Patients with cognitive impairment who are unable to follow instructions (3) Patients with pulmonary dysfunction (4) Other patients who are judged inappropriate to the experiment by the researcher

Sites / Locations

  • SNUH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

preoxygenation

Arm Description

Taking 8 deep breaths at 10 l/min of 100% oxygen for 1 minute with forced inspiration for pre-oxygenation

Outcomes

Primary Outcome Measures

Hypotension during anesthesia induction
When mean blood pressure decreases to less than 60 mmHg at least once from the administration of anesthetic agent to just before intubation

Secondary Outcome Measures

Systolic blood pressure
systolic blood pressure with non-invasive blood pressure at 1-minute intervals.
Diastolic blood pressure
diastolic blood pressure with non-invasive blood pressure at 1-minute intervals.
Heart rate
heart rate which was measured continuously.
Perfusion index
Perfusion index from Radical-7® Pulse CO-Oximeter® which was measured continously.
Pulse oximetry plethysmographic waveform; ΔPOP
Respiratory variations in the pulse oximetry plethysmographic waveform amplitude
Pleth Variability Index (PVi®)
the relative variability of the pleth waveform (perfusion index) detected from a Radical-7® Pulse CO-Oximeter®
Saturation of percutaneous oxygen
from a Radical-7® Pulse CO-Oximeter®

Full Information

First Posted
July 23, 2021
Last Updated
August 3, 2021
Sponsor
Seoul National University Hospital
Collaborators
GEMSKOREA
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1. Study Identification

Unique Protocol Identification Number
NCT04991220
Brief Title
Evaluation of the Changes of Pleth Variability Index During Preoxygenation for Predicting Hypotension
Official Title
Evaluation of the Changes of Pleth Variability Index During Preoxygenation for Predicting Hypotension During Induction of Anesthesia in Surgical Patients; Prospective Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2021 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
GEMSKOREA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to investigate whether the change in pleth variation index (PVI) according to preoxygenation can predict hypotension during anesthesia induction.
Detailed Description
In patients with hypovolemia or dehydration, pulse pressure variation can be increased by spontaneous forced inspiratory breathing. PVI is a noninvasive method of indicator of fluid responsiveness like purse pressure variation. We expected that the amount of change in PVI between at the time of entering operating room and after preoxygenation with forced inspiration method could be different depending on the patient's volume status. After entering operating room, monitoring devices, anesthesia depth sensor, and Radical-7® Pulse CO-Oximeter® are attached. Patients rest for 5 minutes, and then baseline systolic blood pressure, diastolic blood pressure, mean blood pressure, and heart rate are collected every 1-minute. Pleth variability index (PVI), perfusion index (PI) are also measured continuously. For pre-oxygenation of anesthesia, take 8 deep breaths at flow 10 l/min of 100% oxygen for 1 minute with maximally forced inspiration. After that, for 2 minutes, patients breathe as usual while maintaining oxygen supply. until tracheal intubation or laryngeal mask insertion. Anesthesia is induced with target concentration infusion of 4.0 ng/ml of remifentanil and 4.0 ug/ml of propofol. When the patient loses consciousness, rocuronium 1.0 mg/kg is administrated and endotracheal tube or laryngeal mask is inserted 2 minutes after. PVI, PI, blood pressure, and heart rate are measured until tracheal intubation or laryngeal mask insertion. Anesthesia induction-related hypotension is defined as a decrease in mean arterial pressure below 60 mmHg at any timepoint from baseline parameter collection to until airway device insertion. The parameters are analyzed by comparing between groups with and without anesthesia induction-related hypotension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension on Induction
Keywords
Hypovolemia, Pulse Wave Analysis, Hypotension, Anesthesia, General

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preoxygenation
Arm Type
Experimental
Arm Description
Taking 8 deep breaths at 10 l/min of 100% oxygen for 1 minute with forced inspiration for pre-oxygenation
Intervention Type
Procedure
Intervention Name(s)
Preoxygenation
Intervention Description
Taking 8 deep breaths at 10 l/min of 100% oxygen for 1 minute with forced inspiration for pre-oxygenation
Primary Outcome Measure Information:
Title
Hypotension during anesthesia induction
Description
When mean blood pressure decreases to less than 60 mmHg at least once from the administration of anesthetic agent to just before intubation
Time Frame
from start of anesthesia induction to just before intubation
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
systolic blood pressure with non-invasive blood pressure at 1-minute intervals.
Time Frame
from entering operating room to just before intubation
Title
Diastolic blood pressure
Description
diastolic blood pressure with non-invasive blood pressure at 1-minute intervals.
Time Frame
from entering operating room to just before intubation
Title
Heart rate
Description
heart rate which was measured continuously.
Time Frame
from entering operating room to just before intubation
Title
Perfusion index
Description
Perfusion index from Radical-7® Pulse CO-Oximeter® which was measured continously.
Time Frame
from entering operating room to just before intubation
Title
Pulse oximetry plethysmographic waveform; ΔPOP
Description
Respiratory variations in the pulse oximetry plethysmographic waveform amplitude
Time Frame
from the administration of anesthetic agent to just before intubation
Title
Pleth Variability Index (PVi®)
Description
the relative variability of the pleth waveform (perfusion index) detected from a Radical-7® Pulse CO-Oximeter®
Time Frame
from entering operating room to just before intubation
Title
Saturation of percutaneous oxygen
Description
from a Radical-7® Pulse CO-Oximeter®
Time Frame
from entering operating room to just before intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients undergoing elective surgery under general anesthesia Exclusion Criteria: (1) American Society of Anesthesiologists (ASA) physical status classification III or higher (2) Patients with cognitive impairment who are unable to follow instructions (3) Patients with pulmonary dysfunction (4) Other patients who are judged inappropriate to the experiment by the researcher
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoon Jung Kim
Phone
+82-10-9088-6452
Email
imovax4@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Soo Kim, M.D., PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
SNUH
City
Seoul
State/Province
Jongro Gu
ZIP/Postal Code
15710
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
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Evaluation of the Changes of Pleth Variability Index During Preoxygenation for Predicting Hypotension

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