PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intraoperative Hypotension
• Intervention / Treatment: Behavioral: PPI guided strategies; Behavioral: Empirical strategies

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhiqiang Zhou, Dr.; Phone Number: 862783663173; Email: zqzhou@tjh.tjmu.edu.cn

Study Locations

• China
  • Wuhan, China, 430030
    • Recruiting
    • Zhiqiang Zhou
    • Contact: Zhiqiang Zhou; Phone Number: +862783663173; Email: zqzhou@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PPI guided strategies; The decision making for prevention and treatment of hypotension was PPI guided to maintain the PPI between 1 and 3.	Behavioral: PPI guided strategies; 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.
Other: conventional strategies; The decision making for prevention and treatment of hypotension dependent on the experience of anesthesiologist.	Behavioral: Empirical strategies; Fluid therapy or vasoconstriction depended on experiences of anesthetic staffs.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: zhiqiang zhou
• Investigators: Principal Investigator: Zhiqiang Zhou, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: March 19, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 31, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Intraoperative hypotension; General anesthesia; Non-cardiac surgery; Peripheral perfusion indexI
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: TJ-IRB20230247

Drug and device information, study documents

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