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CompletedNCT06589674Updated May 30, 2025

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

An observational study in Anesthesia Induced Hypotension and Hypotension Drug-Induced, sponsored by Kocaeli City Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by Kocaeli City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
126
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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

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Conditions studied

  • Anesthesia Induced Hypotension
  • Hypotension Drug-Induced

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Keywords

  • Anesthesia Induction
  • Hypotension Prediction
  • Pleth Variability Index (PVI)
  • Diastolic Shock Index (DSI)
  • Hemodynamic Monitoring
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In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 126 is above the median of 84 across 294 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Kocaeli City Hospital is the lead sponsor of 38 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
126 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testPulse variability index measurement

    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

  • OtherDiastolic shock index

    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

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What researchers measure

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

    Time frame: First 20 minutes after induction of anesthesia

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Study locations

1 site
  • Kocaeli City Hospital
    Kocaeli, Izmıt 41100, Turkey
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References and documents

Publications

  • 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. PubMed 32296976 ↗
  • 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. PubMed 36480818 ↗
  • 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. PubMed 26529657 ↗
  • 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. PubMed 34687923 ↗
  • 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. PubMed 28974066 ↗
  • 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. PubMed 37639751 ↗

Individual participant data

Plan to share: No — Sharing of patient data is prohibited by the institution and may be requested from the institution with appropriate request.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06589674
Lead sponsor
Kocaeli City Hospital
Responsible party
Ahmet Yuksek (Md, Kocaeli City Hospital) — Principal investigator
First posted
Sep 19, 2024
Start date
Aug 8, 2024
Primary completion
Feb 15, 2025
Completion
Mar 15, 2025
Last update
May 30, 2025

Study contacts

Ahmet Yuksek, Associate Proffessor
study director · Kocaeli City Hospital
Ayse Sencan, Md
principal investigator · Kocaeli City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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