PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension

NCT05792696 | Unknown

• 1 other identifier: TJ-IRB20230247
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Hypotension

Keywords

Intraoperative hypotension; Peripheral perfusion indexI; General anesthesia; Non-cardiac surgery

Outcome Measures

Primary Outcomes (1)

• time-weighted average of hypotension (TWA)<65mmHg

  total area under MAP\<65 mmHg/surgery length

  Intraoperative (between anesthesia induction and tracheal extubation)

Secondary Outcomes (10)

• Rate of hypotension after anesthesia induction

  from anesthesia induction to 15 minutes after then

• Cumulative number of intraoperative hypotension episodes

  Intraoperative (between anesthesia induction and tracheal extubation)

• Cumulative time of intraoperative hypotension period

  Intraoperative (between anesthesia induction and tracheal extubation)

• Proportion of time with hypotension

  Intraoperative (between anesthesia induction and tracheal extubation)

• time-weighted average of hypertension (TWA)>100mmHg

  Intraoperative (between anesthesia induction and tracheal extubation)

Study Arms (2)

PPI guided strategies

EXPERIMENTAL

The decision making for prevention and treatment of hypotension was PPI guided to maintain the PPI between 1 and 3.

Behavioral: PPI guided strategies

conventional strategies

OTHER

The decision making for prevention and treatment of hypotension dependent on the experience of anesthesiologist.

Behavioral: Empirical strategies

Interventions

PPI guided strategies BEHAVIORAL

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.

PPI guided strategies

Empirical strategies BEHAVIORAL

Fluid therapy or vasoconstriction depended on experiences of anesthetic staffs.

conventional strategies

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• years and older ASA Physical Status 1-3 general anesthesia arterial catheterization procedures last more than 2 hours communicate normally in Mandarin

You may not qualify if:

• 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

Sponsors & Collaborators

• zhiqiang zhou: lead

Study Sites (1)

Zhiqiang Zhou

Wuhan, 430030, China

RECRUITING

Study Officials

• Zhiqiang Zhou

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiqiang Zhou, Dr.

CONTACT

862783663173; zqzhou@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: March 31, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 9, 2024

Record last verified: 2023-12

Locations

CN (1)