- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06589674
Comparison of Pleth Variability Index vs. Diastolic Shock Index for Predicting Hypotension During Anesthesia Induction
Comparison of the Effectiveness of Pleth Variability Index and Diastolic Shock Index in Predicting Hypotension During Anesthesia Induction
Study Overview
Status
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Izmıt
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Kocaeli, Izmıt, Turkey, 41100
- Kocaeli City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prediction of anesthesia-induced hypotension
Time Frame: First 20 minutes after induction of anesthesia
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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
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First 20 minutes after induction of anesthesia
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: AYŞE ŞENCAN, MD, Kocaeli City Hospital
- Study Director: Ahmet Yuksek, Associate Proffessor, Kocaeli City Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-69
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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