PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension

Intraoperative Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792696
• Other study ID #: TJ-IRB20230247
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2023
• Source: Tongji Hospital
• Contact: Zhiqiang Zhou, Dr.
• Phone: 862783663173
• Email: zqzhou[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intraoperative Hypotension

Intervention

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.
• Empirical strategies
Fluid therapy or vasoconstriction depended on experiences of anesthetic staffs.

Locations

Country	Name	City	State
China	Zhiqiang Zhou	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
zhiqiang zhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time-weighted average of hypotension (TWA)<65mmHg	total area under MAP<65 mmHg/surgery length	Intraoperative (between anesthesia induction and tracheal extubation)
Secondary	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
Secondary	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)
Secondary	Cumulative time of intraoperative hypotension period	Cumulative time of MAP<65mmHg	Intraoperative (between anesthesia induction and tracheal extubation)
Secondary	Proportion of time with hypotension	Proportion of cumulative time of intraoperative hypotension period and the anesthesia time	Intraoperative (between anesthesia induction and tracheal extubation)
Secondary	time-weighted average of hypertension (TWA)>100mmHg	total area under MAP>100 mmHg/surgery length	Intraoperative (between anesthesia induction and tracheal extubation)
Secondary	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)
Secondary	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
Secondary	arterial partial pressure of oxygen (PaO2)/inspired fraction of oxygen (FiO2)	PaO2/FiO2	5 minutes before and 5 minutes after the end of surgery
Secondary	intraoperative urine output	urine output during the surgery	Intraoperative (between anesthesia induction and tracheal extubation)
Secondary	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