Clinical trial NCT05792696: PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension
Official title: Effectiveness of Peripheral Perfusion Index Guided Strategies for the Prevention and Treatment of Hypotension: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraoperative Hypotension
Keywords: Intraoperative hypotension
Peripheral perfusion indexI
General anesthesia
Non-cardiac surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 54
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: time-weighted average of hypotension (TWA)<65mmHg
timeFrame: Intraoperative (between anesthesia induction and tracheal extubation)
Secondary outcomes:
measure: Rate of hypotension after anesthesia induction
timeFrame: from anesthesia induction to 15 minutes after then
measure: Cumulative number of intraoperative hypotension episodes
timeFrame: Intraoperative (between anesthesia induction and tracheal extubation)
measure: Cumulative time of intraoperative hypotension period
timeFrame: Intraoperative (between anesthesia induction and tracheal extubation)
measure: Proportion of time with hypotension
timeFrame: Intraoperative (between anesthesia induction and tracheal extubation)
measure: time-weighted average of hypertension (TWA)>100mmHg
timeFrame: Intraoperative (between anesthesia induction and tracheal extubation)
measure: Cumulative number of intraoperative hypertension episodes
timeFrame: Intraoperative (between anesthesia induction and tracheal extubation)
measure: postoperative plasma concentration of lactic acid
timeFrame: 5 minutes before and 5 minutes after the end of surgery
measure: arterial partial pressure of oxygen (PaO2)/inspired fraction of oxygen (FiO2)
timeFrame: 5 minutes before and 5 minutes after the end of surgery
measure: intraoperative urine output
timeFrame: Intraoperative (between anesthesia induction and tracheal extubation)
measure: the rate of acute kidney injury (AKI)
timeFrame: within 7 days after the end of surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhiqiang Zhou
Study officials:
affiliation: Tongji Hospital
name: Zhiqiang Zhou
role: PRINCIPAL_INVESTIGATOR
References: