Comparison of Pleth Variability Index vs. Diastolic Shock Index for Predicting Hypotension During Anesthesia Induction

NCT06589674 | Completed

• 1 other identifier: 2024-69
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Induced Hypotension; Hypotension Drug-Induced

Keywords

Anesthesia Induction; Hypotension Prediction; Pleth Variability Index (PVI); Diastolic Shock Index (DSI); Hemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

• Prediction of anesthesia-induced hypotension

  Anesthesia-induced hypotension is a significant drop in blood pressure that occurs during the induction or maintenance of anesthesia.Arterial hypotension was defined as systolic blood pressure (SBP) ; 90 mmHg in at least one measurement during this period or norepinephrine administered at a dose of ;6 mcg/min at lea

  First 20 minutes after induction of anesthesia

Study Arms (1)

General Anesthesia Group

This group includes all study patients who underwent elective lumbar spine surgery under general anesthesia. In these patients, both PVI and DSI measurements will be performed before and during anesthesia induction.

Diagnostic Test: Pulse variability index measurement; Other: Diastolic shock index

Interventions

Pulse variability index measurement DIAGNOSTIC_TEST

Peripheral perfusion index (PI) is an easy-to-implement and low-cost monitoring procedure obtained by interpreting non-invasive data obtained from pulse oximetry via plethysmography. It is a tool that allows interpretation of fluid status through changes in pulse oximetry waves caused by respiration. High perfusion indices are interpreted as low arterial tone. Changes in perfusion index are interpreted as indicators of vascular tone or fluid deficit problems in patients. The ratio of the highest and lowest PI values gives the Pleth Variability Index (PVI) (3,4). Hypotension can be predicted during anesthesia induction with PVI

Also known as: PVI

General Anesthesia Group

Diastolic shock index OTHER

The Diastolic Shock Index (DSI) is a hemodynamic parameter calculated by dividing the heart rate (HR) by the diastolic blood pressure (DBP). It reflects the balance between cardiac output and systemic vascular resistance, particularly in critically ill patients. A higher DSI can indicate impaired vascular resistance and may be useful for predicting the need for vasopressor support, especially in conditions like septic shock. However, its application in predicting hypotension during anesthesia induction is still under investigation.

Also known as: DSI

General Anesthesia Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who do not agree to participate in the study
• Emergency surgeries
• Patients who will undergo surgery under spinal anesthesia
• Patients diagnosed with autonomic neuropathy
• Patients undergoing surgery with inotropic support

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmıt, 41100, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 32296976 BACKGROUND

• 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.

  PMID: 36480818 BACKGROUND

• 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.

  PMID: 26529657 BACKGROUND

• 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.

  PMID: 34687923 BACKGROUND

• 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.

  PMID: 28974066 BACKGROUND

• 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.

  PMID: 37639751 BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ahmet Yuksek, Associate Proffessor

  Kocaeli City Hospital

  STUDY DIRECTOR

• Ayse Sencan, Md

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: August 8, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 15, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)