Intraoperative HypotensionNCT05792696
PPI Guided Strategies for Prevention and Treatment of Intraoperative Hypotension
A study testing PPI guided strategies and Empirical strategies in people with Intraoperative Hypotension, run by zhiqiang zhou at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- PPI guided strategies and Empirical strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65 years and older ASA Physical Status 1-3 general anesthesia arterial catheterization procedures last more than 2 hours communicate normally in Mandarin
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhiqiang Zhou
Wuhan, 430030
Zhiqiang Zhou, +862783663173, zqzhou@tjh.tjmu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraoperative Hypotension
- Being tested
- PPI guided strategies, Empirical strategies
- Keywords
- Intraoperative hypotension, Peripheral perfusion indexI, General anesthesia, Non-cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPI guided strategiesBehavioural
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 strategiesBehavioural
Fluid therapy or vasoconstriction depended on experiences of anesthetic staffs.
| Study group | Role | What they receive |
|---|---|---|
| PPI guided strategies | Experimental | The decision making for prevention and treatment of hypotension was PPI guided to maintain the PPI between 1 and 3. Receives: Behavioral: PPI guided strategies |
| conventional strategies | Other | The decision making for prevention and treatment of hypotension dependent on the experience of anesthesiologist. Receives: Behavioral: Empirical strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
time-weighted average of hypotension (TWA)<65mmHg
total area under MAP<65 mmHg/surgery length
Measured: Intraoperative (between anesthesia induction and tracheal extubation)
Secondary outcomes (10)
Rate of hypotension after anesthesia induction
the number of participants of hypotension/ the number of each group
Measured: 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
Measured: Intraoperative (between anesthesia induction and tracheal extubation)
Cumulative time of intraoperative hypotension period
Cumulative time of MAP<65mmHg
Measured: Intraoperative (between anesthesia induction and tracheal extubation)
Proportion of time with hypotension
Proportion of cumulative time of intraoperative hypotension period and the anesthesia time
Measured: Intraoperative (between anesthesia induction and tracheal extubation)
time-weighted average of hypertension (TWA)>100mmHg
total area under MAP>100 mmHg/surgery length
Measured: 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
Measured: Intraoperative (between anesthesia induction and tracheal extubation)
postoperative plasma concentration of lactic acid
Plasma concentration of lactic acid in the end of surgery
Measured: 5 minutes before and 5 minutes after the end of surgery
arterial partial pressure of oxygen (PaO2)/inspired fraction of oxygen (FiO2)
PaO2/FiO2
Measured: 5 minutes before and 5 minutes after the end of surgery
intraoperative urine output
urine output during the surgery
Measured: 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
Measured: within 7 days after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Jan 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- zhiqiang zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, zhiqiang zhou, Tongji Hospital
- Investigators
- Zhiqiang Zhou, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792696
- Sponsor's protocol ID
- TJ-IRB20230247
- Status last verified
- Dec 2023
- First submitted
- 19 Mar 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Peripheral Perfusion Index Guided Strategies for the Prevention and Treatment of Hypotension: a Randomized Trial
- ClinicalTrials.gov ID
- NCT05792696
- Acronym / sponsor ID
- TJ-IRB20230247
- Conditions
- Intraoperative Hypotension
- Keywords
- Intraoperative hypotension, Peripheral perfusion indexI, General anesthesia, Non-cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- zhiqiang zhouUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI guided strategies | Experimental | Behavioral: PPI guided strategiesThe decision making for prevention and treatment of hypotension was PPI guided to maintain the PPI between 1 and 3. |
| conventional strategies | Other | Behavioral: Empirical strategiesThe decision making for prevention and treatment of hypotension dependent on the experience of anesthesiologist. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years and older ASA Physical Status 1-3 general anesthesia arterial catheterization procedures last more than 2 hours communicate normally in Mandarin
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPI guided strategiesFor 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. | Behavioural | PPI guided strategies |
| Empirical strategiesFluid therapy or vasoconstriction depended on experiences of anesthetic staffs. | Behavioural | conventional strategies |
Primary outcome
time-weighted average of hypotension (TWA)<65mmHg
Time frame: Intraoperative (between anesthesia induction and tracheal extubation)
total area under MAP<65 mmHg/surgery length
10 secondary outcomes
Rate of hypotension after anesthesia induction
Time frame: from anesthesia induction to 15 minutes after then
Cumulative number of intraoperative hypotension episodes
Time frame: Intraoperative (between anesthesia induction and tracheal extubation)
Cumulative time of intraoperative hypotension period
Time frame: Intraoperative (between anesthesia induction and tracheal extubation)
Proportion of time with hypotension
Time frame: Intraoperative (between anesthesia induction and tracheal extubation)
time-weighted average of hypertension (TWA)>100mmHg
Time frame: Intraoperative (between anesthesia induction and tracheal extubation)
Cumulative number of intraoperative hypertension episodes
Time frame: Intraoperative (between anesthesia induction and tracheal extubation)
postoperative plasma concentration of lactic acid
Time frame: 5 minutes before and 5 minutes after the end of surgery
arterial partial pressure of oxygen (PaO2)/inspired fraction of oxygen (FiO2)
Time frame: 5 minutes before and 5 minutes after the end of surgery
intraoperative urine output
Time frame: Intraoperative (between anesthesia induction and tracheal extubation)
the rate of acute kidney injury (AKI)
Time frame: within 7 days after the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiqiang Zhou principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPI guided strategies and Empirical strategies in people with Intraoperative Hypotension, run by zhiqiang zhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiqiang Zhou, Dr. (862783663173, zqzhou@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time-weighted average of hypotension (TWA)<65mmHg (time frame: Intraoperative (between anesthesia induction and tracheal extubation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.