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Clinical Trials/NCT04120012
NCT04120012
Completed
Not Applicable

The Effect of Frailty to Intraoperative Hemodynamic Instability and Perioperative Complications in the Elderly: a Prospective Observational Study

Peking Union Medical College Hospital1 site in 1 country166 target enrollmentNovember 20, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fragility
Sponsor
Peking Union Medical College Hospital
Enrollment
166
Locations
1
Primary Endpoint
Incidence of intraoperative hypotension
Status
Completed
Last Updated
last year

Overview

Brief Summary

With the progression of population aging, the number of elderly patients undergoing surgery is increasing as well. However, as the condition of health differs greatly between individual elderly patients even of the same age, it is a necessity to evaluate elderly patients thoroughly and individually for better management of perioperative care.

Frailty is a condition in which patients are impaired at physical reserve and homeostatic control. Frail elderly people are at higher risk of morbidity and mortality after exposure to a stressor. Frail patients are at higher risk of perioperative complications and longer hospital stay. However, there has been no standard criteria or tool to evaluate frailty in the elderly. Neither has there been enough evidence explaining the mechanism between frailty and increased perioperative complications. Therefore, in this study we aim to discover the relationship between frailty and intraoperative hemodynamic instability, as well as perioperative complications in the elderly patients, hoping to find an adequate and practical model for preoperative assessment in the elderly hopefully for better perioperative outcome.

Registry
clinicaltrials.gov
Start Date
November 20, 2019
End Date
May 25, 2022
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • age≥65 years
  • elective major non-cardiac surgery
  • general anesthesia
  • American Society of Anesthesiologists(ASA) grade I,II,III
  • study protocol fully understood by the patients, written consent obtained

Exclusion Criteria

  • emergency surgery
  • in active state of infection or inflammation
  • chronic kidney disease(CKD) stage 5
  • having conditions that would interfere accurate measurement of upper extremity blood pressure (e.g. subclavian artery stenosis)
  • having conditions that would interfere assessment of frailty assessment (e.g. mental disorder, hearing disorder)
  • study protocol not fully understood, no written consent obtained

Outcomes

Primary Outcomes

Incidence of intraoperative hypotension

Time Frame: Intraoperative

Intraoperative hypotension includes post induction hypotension(PIH), early intraoperative hypotension(eIOH) and late intraoperative hypotension(lIOH). Hypotension is defined as a systolic blood pressure less than 90mmHg or a relative decrease more than 30% compared to baseline blood pressure, or mean arterial pressure less than 65mmHg or a decrease more than 30% compared to baseline. PIH is defined as a hypotension within 20 minutes after anesthesia induction, or before surgical incision. eIOH is defined as hypotension within 30 minutes after the start of surgery. lIOH is defined as hypotension that happen 30 minutes after the start of surgery until the end of surgery.

Incidence of intraoperative hemodynamic instability

Time Frame: Intraoperative

Intraoperative hemodynamic instability is defined as a definite change of systolic blood pressure, or mean arterial pressure, or diastolic pressure, or pulse pressure more than 15% or the need for vasoactive agents.

Secondary Outcomes

  • Incidence of postoperative complications(Within 30days after surgery)

Study Sites (1)

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