PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intraoperative Hypotension

Intervention / Treatment
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* Behavioral: PPI guided strategies
* Behavioral: Empirical strategies


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPI guided strategies<br>The decision making for prevention and treatment of hypotension was PPI guided to maintain the PPI between 1 and 3. | Behavioral: PPI guided strategies<br>* For targeted MAP or lower, if PPI<1, more fluid therapy. if PPI>3, vasoconstriction therapy. For MAP<65mmHg and 1<=PPI<3, test bolus of 250 ml crystalloid fluid.<br>|
| Other: conventional strategies<br>The decision making for prevention and treatment of hypotension dependent on the experience of anesthesiologist. | Behavioral: Empirical strategies<br>* Fluid therapy or vasoconstriction depended on experiences of anesthetic staffs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time-weighted average of hypotension (TWA)<65mmHg | total area under MAP<65 mmHg/surgery length | Intraoperative (between anesthesia induction and tracheal extubation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hypotension after anesthesia induction | the number of participants of hypotension/ the number of each group | from anesthesia induction to 15 minutes after then | 
| Cumulative number of intraoperative hypotension episodes | Cumulative number of MAP<65mmHg and last at least for three minutes | Intraoperative (between anesthesia induction and tracheal extubation) | 
| Cumulative time of intraoperative hypotension period | Cumulative time of MAP<65mmHg | Intraoperative (between anesthesia induction and tracheal extubation) | 
| Proportion of time with hypotension | Proportion of cumulative time of intraoperative hypotension period and the anesthesia time | Intraoperative (between anesthesia induction and tracheal extubation) | 
| time-weighted average of hypertension (TWA)>100mmHg | total area under MAP>100 mmHg/surgery length | Intraoperative (between anesthesia induction and tracheal extubation) | 
| Cumulative number of intraoperative hypertension episodes | Cumulative number of MAP>100 mmHg and last at least for three minutes | Intraoperative (between anesthesia induction and tracheal extubation) | 
| postoperative plasma concentration of lactic acid | Plasma concentration of lactic acid in the end of surgery | 5 minutes before and 5 minutes after the end of surgery | 
| arterial partial pressure of oxygen (PaO2)/inspired fraction of oxygen (FiO2) | PaO2/FiO2 | 5 minutes before and 5 minutes after the end of surgery | 
| intraoperative urine output | urine output during the surgery | Intraoperative (between anesthesia induction and tracheal extubation) | 
| the rate of acute kidney injury (AKI) | the number of participants with AKI/ the number of each group | within 7 days after the end of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General anesthesia, Intraoperative hypotension, Peripheral perfusion indexI, Non-cardiac surgery