Clinical trial NCT04991220: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension on Induction
Keywords: Hypovolemia
Pulse Wave Analysis
Hypotension
Anesthesia, General
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: GEMSKOREA
First posted: 2021-08-05
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Hypotension during anesthesia induction
timeFrame: from start of anesthesia induction to just before intubation
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: from entering operating room to just before intubation
measure: Diastolic blood pressure
timeFrame: from entering operating room to just before intubation
measure: Heart rate
timeFrame: from entering operating room to just before intubation
measure: Perfusion index
timeFrame: from entering operating room to just before intubation
measure: Pulse oximetry plethysmographic waveform; ΔPOP
timeFrame: from the administration of anesthetic agent to just before intubation
measure: Pleth Variability Index (PVi®)
timeFrame: from entering operating room to just before intubation
measure: Saturation of percutaneous oxygen
timeFrame: from entering operating room to just before intubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
affiliation: Seoul National University Hospital
name: Hee Soo Kim, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
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