Shock Index, Modified Shock Index and Age-related Shock Index for Predicting Post-spinal Hypotension in Elderly Patients

Does Shock Index, Modified Shock Index and Age-Related Shock Index Have a Predictive Value in Predicting the Risk of Post-spinal Hypotension in Elderly Patients

Aim of this prospective observational study is to investigate whether shock index(SI), modified shock index(MSI) and age related shock index(ASI) have any predictive value in predicting post-spinal hypotension which may develop in patients over 65 years of age, who are planned to undergo transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.

Study Overview

• Status: Unknown
• Conditions: Anesthesia Morbidity; Geriatrics; Intraoperative Hypotension; Procedural Hypotension
• Intervention / Treatment: Procedure: spinal anesthesia

Detailed Description

During the aging process, many important changes occur in the cardiovascular system. In elderly patients undergoing surgery, systemic vascular resistance is generally high but accompanying dehydration is a very common condition. The hemodynamic status of these patients may be compromised during spinal anesthesia due to the decrease in both systemic vascular resistance (SVR) and cardiac preload. Intraoperative hypotension may develop after spinal anesthesia. Intraoperative hypotension can prolong hospital stay by causing serious complications, and it can significantly affect mortality rates. Predicting hypotension which may develop after spinal anesthesia, can save time to decide, prepare and apply preventive interventions.

Shock index (SI) has been defined as the ratio of heart rate (HR) to systolic blood pressure (SBP). SI is an easy and non-invasive marker used in hypovolemia and early diagnosis of shock. SI is usually <0.7. In case of acute hypovolemia and circulatory failure, this ratio increases. It has been stated that in critical patients, diastolic blood pressure (DBP) will drop earlier than SBP, and the mean blood pressure will be a more accurate marker to assess the severity of the disease. For this reason, the modified shock index (MSI), which is obtained by dividing the heart rate by the mean arterial pressure (MAP), has been defined. MSI> 1.3 indicates a hypodynamic state.

The Age Shock Index (ASI) is defined by multiplying SI by age. In trauma patients, this index has been shown to correlate with a higher mortality rate with an increase greater than 50. Since age affects the physiological reserve negatively, it has been stated that ASI is a better predictor of 48-hour mortality compared to heart rate, SBP or SI. In studies evaluating ASI, SI and MSI to predict post-intubation hypotension; pre-intubation SI, MSI, ASI values have been shown to be the independent predictors of post-intubation hypotension.

Aim of this prospective observational study is to investigate whether SI, MSI and ASI have any predictive value in predicting post-spinal hypotension which may develop in patients over 65 years of age, who are planned to undergo transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.

The secondary objective is to compare the two groups in terms of preoperative and postoperative blood tests, and to determine whether the patients were admitted to intensive care or postanesthesia care unit. If the patient was admitted, length of unit and hospital stay and postoperative complications (if developed any) will be recorded. In addition, the investigators will examine whether intraoperative hypotension has any negative effects.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: İsmail Aytac; Phone Number: 05056340369; Email: aytacismail1972@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Recruiting
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Paients undergo transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.

Description

Inclusion Criteria:

• ≥65 years old

Exclusion Criteria:

duration of operation>120 minutes ASA>3

• Patients with valvular heart disease that disrupts hemodynamics
• Patients with arrhythmia (such as atrial fibrillation with rapid ventricular rate) that disrupts hemodynamics
• severe heart failure
• mental and motor problems
• neuropsychiatric disorders

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
post-spinal hypotension; Patients with a fall in SBP by 25% of the preoperative baseline or an absolute value <90 mm of Hg; MAP ≤65 mmHg after spinal anesthesia	Procedure: spinal anesthesia; patients undergoing transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.
post-spinal normotension; Patients with Fall of SBP<%25 of the preoperative value or absolute value >90 mm Hg, MAP>65 mmHg	Procedure: spinal anesthesia; patients undergoing transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SI	shock index: defined as the ratio of heart rate (HR) to systolic blood pressure (SBP)	preoperative
MSI	Modified Shock İndex: obtained by dividing the heart rate by the mean arterial pressure	preoperative
ASI	Age Shock Index (ASI) is defined by multiplying shock index(SI) by age	preoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CCI	Charlson Comorbidity Index	preoperative
length of hospital stay	length of hospital stay after operation	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: İsmail Aytac, Ankara City Hospital Anesthesiology Department

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: July 18, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: post-spinal hypotension; spinal anesthesia; geriatric anesthesia; Intraoperative Hypotension; shock index; modified shock index; age-related shock index
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Shock; Hypotension; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: E1-20-787

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No