PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension

Not Applicable

Recruiting

• Conditions: Intraoperative Hypotension
• Interventions: Behavioral: PPI guided strategies; Behavioral: Empirical strategies

• Registration Number: NCT05792696
• Lead Sponsor: zhiqiang zhou

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.

Study Timeline

• Study First Submitted: 2023-03-19
• Study First Submitted QC: 2023-03-30
• Study First Posted: 2023-03-31
• Status Verified: 2023-12
• Study Start: 2024-01-01
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPI guided strategies	PPI guided strategies	The decision making for prevention and treatment of hypotension was PPI guided to maintain the PPI between 1 and 3.
conventional strategies	Empirical strategies	The decision making for prevention and treatment of hypotension dependent on the experience of anesthesiologist.

Primary Outcome Measures

Name	Time	Method
time-weighted average of hypotension (TWA)<65mmHg	Intraoperative (between anesthesia induction and tracheal extubation)	total area under MAP\<65 mmHg/surgery length

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhiqiang Zhou; 🇨🇳 Wuhan, China