Clinical trial NCT06589674: Comparison of Pleth Variability Index vs. Diastolic Shock Index for Predicting Hypotension During Anesthesia Induction
Official title: Comparison of the Effectiveness of Pleth Variability Index and Diastolic Shock Index in Predicting Hypotension During Anesthesia Induction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Induced Hypotension
Hypotension Drug-Induced
Keywords: Anesthesia Induction
Hypotension Prediction
Pleth Variability Index (PVI)
Diastolic Shock Index (DSI)
Hemodynamic Monitoring
Lead sponsor: Kocaeli City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will undergo elective lumbar spine surgery in Kocaeli City Hospital operating rooms constitute the study universe.

Brief summary: This study aims to explore the frequent occurrence of hypotension during anesthesia induction due to anesthetic drugs or fasting. Predicting this condition is important for patient safety and anesthesia management. The study examines two indices: the Pleth Variability Index (PVI), derived from pulse oximeter readings, and the Diastolic Shock Index (DSI), calculated using heart rate and diastolic blood pressure. While PVI is a well-known method, DSI has been less explored in predicting anesthesia-related hypotension. The study aims to compare the effectiveness of these two indices in forecasting hypotension during anesthesia induction.

Detailed description: Hypotension is frequently observed during anesthesia induction due to the effects of anesthetic drugs on hemodynamics and the requirement of a specific fasting period before surgery. Induction-related hypotension can lead to decreased tissue perfusion and, consequently, secondary organ damage. Predicting anesthesia-induced hypotension in advance contributes to better anesthesia management and patient safety (1). Induction-related hypotension is defined as arterial hypotension occurring within the first 20 minutes after anesthesia induction or until the start of the surgery. Arterial hypotension is identified when mean systolic arterial pressure (MAP) decrease \> 20% or MAP \<65 mmHg or when norepinephrine is administered at a dose \>;6 mcg/min at least once during this period (2).

The peripheral perfusion index (PI) is a simple, cost-effective monitoring method derived from non-invasive plethysmographic data using pulse oximetry. It provides an assessment of fluid status based on respiratory changes in pulse oximeter waves, with higher PI values indicating lower arterial tone. Changes in PI are interpreted as signs of vascular tone or fluid deficit issues in patients. The ratio of the highest and lowest PI values yields the Pleth Variability Index (PVI) (3,4). PVI can be used to predict hypotension during anesthesia induction (5).

Cardiac output (CO) is calculated by multiplying systemic vascular resistance (SVR) and heart rate (HR). In septic and shock patients, CO may be low, often due to decreased SVR. The autonomic system tries to maintain CO by increasing HR in response to the reduced SVR (6). Systolic and diastolic shock indices are obtained by dividing the HR by systolic and diastolic blood pressures, respectively. The diastolic shock index has been evaluated in studies to predict vasopressor response in septic patients (7). A high shock index has been associated with early vasopressor initiation and better prognosis. However, no study has yet examined the predictive power of the diastolic shock index, which is related to sympathetic response and systemic vascular resistance, for hypotension following anesthesia induction.

Moreover, the diastolic shock index has not been compared with the more commonly used PVI in terms of their ability to predict hypotension. Therefore, our study aims to test the success of diastolic shock index and PVI measurements in predicting anesthesia-induced hypotension

Eligibility criteria: Inclusion Criteria:

1. Patients with a preoperative fasting period of at least 6 hours
2. Patients scheduled for elective surgery under general anesthesia
3. Patients aged 18-65 with ASA classification I-III
4. Patients undergoing lumbar spinal surgery

Exclusion Criteria:

1. Patients who do not agree to participate in the study
2. Emergency surgeries
3. Patients who will undergo surgery under spinal anesthesia
4. Patients diagnosed with autonomic neuropathy
5. Patients undergoing surgery with inotropic support

Primary outcomes:
measure: Prediction of anesthesia-induced hypotension
timeFrame: First 20 minutes after induction of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli City Hospital
state: Izmıt
Study officials:
affiliation: Kocaeli City Hospital
name: Ahmet Yuksek, Associate Proffessor
role: STUDY_DIRECTOR
affiliation: Kocaeli City Hospital
name: Ayse Sencan, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ospina-Tascon GA, Teboul JL, Hernandez G, Alvarez I, Sanchez-Ortiz AI, Calderon-Tapia LE, Manzano-Nunez R, Quinones E, Madrinan-Navia HJ, Ruiz JE, Aldana JL, Bakker J. Diastolic shock index and clinical outcomes in patients with septic shock. Ann Intensive Care. 2020 Apr 16;10(1):41. doi: 10.1186/s13613-020-00658-8.
citation: Ospina-Tascon GA, Garcia-Gallardo G, Orozco N. Using the diastolic shock index to determine when to promptly administer vasopressors in patients with septic shock. Clin Exp Emerg Med. 2022 Dec;9(4):367-369. doi: 10.15441/ceem.22.401. Epub 2022 Dec 8. No abstract available.
citation: Rasmy I, Mohamed H, Nabil N, Abdalah S, Hasanin A, Eladawy A, Ahmed M, Mukhtar A. Evaluation of Perfusion Index as a Predictor of Vasopressor Requirement in Patients with Severe Sepsis. Shock. 2015 Dec;44(6):554-9. doi: 10.1097/SHK.0000000000000481.
citation: Coutrot M, Dudoignon E, Joachim J, Gayat E, Vallee F, Depret F. Perfusion index: Physical principles, physiological meanings and clinical implications in anaesthesia and critical care. Anaesth Crit Care Pain Med. 2021 Dec;40(6):100964. doi: 10.1016/j.accpm.2021.100964. Epub 2021 Oct 24.
citation: Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
citation: Kim YJ, Seo JH, Lee HC, Kim HS. Pleth variability index during preoxygenation could predict anesthesia-induced hypotension: A prospective, observational study. J Clin Anesth. 2023 Nov;90:111236. doi: 10.1016/j.jclinane.2023.111236. Epub 2023 Aug 26.