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

Evaluation of the Changes of Pleth Variability Index During Preoxygenation for Predicting Hypotension During Induction of Anesthesia in Surgical Patients; Prospective Observational Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04991220
Enrollment
96
Registered
2021-08-05
Start date
2021-08-30
Completion date
2022-12-31
Last updated
2021-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension on Induction

Keywords

Hypovolemia, Pulse Wave Analysis, Hypotension, Anesthesia, General

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.

Interventions

PROCEDUREPreoxygenation

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

Sponsors

GEMSKOREA
CollaboratorUNKNOWN
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Diastolic blood pressurefrom entering operating room to just before intubationdiastolic blood pressure with non-invasive blood pressure at 1-minute intervals.
Heart ratefrom entering operating room to just before intubationheart rate which was measured continuously.
Perfusion indexfrom entering operating room to just before intubationPerfusion index from Radical-7® Pulse CO-Oximeter® which was measured continously.
Systolic blood pressurefrom entering operating room to just before intubationsystolic blood pressure with non-invasive blood pressure at 1-minute intervals.
Pleth Variability Index (PVi®)from entering operating room to just before intubationthe relative variability of the pleth waveform (perfusion index) detected from a Radical-7® Pulse CO-Oximeter®
Saturation of percutaneous oxygenfrom entering operating room to just before intubationfrom a Radical-7® Pulse CO-Oximeter®
Pulse oximetry plethysmographic waveform; ΔPOPfrom the administration of anesthetic agent to just before intubationRespiratory variations in the pulse oximetry plethysmographic waveform amplitude

Countries

South Korea

Contacts

Primary ContactYoon Jung Kim
imovax4@naver.com+82-10-9088-6452

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026