PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- Cumulative time of intraoperative hypotension period [Intraoperative (between anesthesia induction and tracheal extubation)]
Cumulative time of MAP<65mmHg
- Proportion of time with hypotension [Intraoperative (between anesthesia induction and tracheal extubation)]
Proportion of cumulative time of intraoperative hypotension period and the anesthesia time
- time-weighted average of hypertension (TWA)>100mmHg [Intraoperative (between anesthesia induction and tracheal extubation)]
total area under MAP>100 mmHg/surgery length
- 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
- 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
- arterial partial pressure of oxygen (PaO2)/inspired fraction of oxygen (FiO2) [5 minutes before and 5 minutes after the end of surgery]
PaO2/FiO2
- intraoperative urine output [Intraoperative (between anesthesia induction and tracheal extubation)]
urine output during the surgery
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- zhiqiang zhou
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TJ-IRB20230247