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Clinical Trials/NCT05792696
NCT05792696
Recruiting
N/A

Effectiveness of Peripheral Perfusion Index Guided Strategies for the Prevention and Treatment of Hypotension: a Randomized Trial

zhiqiang zhou1 site in 1 country54 target enrollmentJanuary 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Intraoperative Hypotension
Sponsor
zhiqiang zhou
Enrollment
54
Locations
1
Primary Endpoint
time-weighted average of hypotension (TWA)<65mmHg
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Intraoperative hypotension is closely related to the poor prognosis of surgery. The study is focused on the effectiveness of maintaining normal peripheral perfusion index (PPI) on time-weighted average of hypotension during anesthesia.

Detailed Description

Intraoperative hypotension is closely related to the poor prognosis of surgery. Hypotension decreased blood flow perfusion of organs, which lead to dysfunction of multiple organs, especially increasing serious complications such as cardio-cerebrovascular events and acute renal injury within 30 days after surgery. The aim of this study is to establish a set of strategies that can effectively prevent and treat intraoperative hypotension, so as to alleviate possible harm to patients from perioperative hypotension. The study is focused on the effectiveness of maintaining normal peripheral perfusion index (PPI) on time-weighted average of hypotension during anesthesia. The lower target mean arterial pressure (MAP) was higher than 65 mmHg. MAP less than 65 mmHg was defined as intraoperative hypotension between induction and tracheal extubation.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
June 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
zhiqiang zhou
Responsible Party
Sponsor Investigator
Principal Investigator

zhiqiang zhou

Principal Investigator

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

  • 65 years and older ASA Physical Status 1-3 general anesthesia arterial catheterization procedures last more than 2 hours communicate normally in Mandarin

Exclusion Criteria

  • abnormal Allen's test higher target than 65 mmHg history of diabetes vascular diseases arrhythmia cardiac function class II and above physical disability, unable to conduct PPI monitoring participated in other clinical studies in the past month

Outcomes

Primary Outcomes

time-weighted average of hypotension (TWA)<65mmHg

Time Frame: Intraoperative (between anesthesia induction and tracheal extubation)

total area under MAP\<65 mmHg/surgery length

Secondary Outcomes

  • Rate of hypotension after anesthesia induction(from anesthesia induction to 15 minutes after then)
  • Cumulative number of intraoperative hypotension episodes(Intraoperative (between anesthesia induction and tracheal extubation))
  • Proportion of time with hypotension(Intraoperative (between anesthesia induction and tracheal extubation))
  • Cumulative time of intraoperative hypotension period(Intraoperative (between anesthesia induction and tracheal extubation))
  • Cumulative number of intraoperative hypertension episodes(Intraoperative (between anesthesia induction and tracheal extubation))
  • time-weighted average of hypertension (TWA)>100mmHg(Intraoperative (between anesthesia induction and tracheal extubation))
  • postoperative plasma concentration of lactic acid(5 minutes before and 5 minutes after the end of surgery)
  • intraoperative urine output(Intraoperative (between anesthesia induction and tracheal extubation))
  • arterial partial pressure of oxygen (PaO2)/inspired fraction of oxygen (FiO2)(5 minutes before and 5 minutes after the end of surgery)
  • the rate of acute kidney injury (AKI)(within 7 days after the end of surgery)

Study Sites (1)

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