Hypotension on InductionPPVfi-PIHNCT07166562
PPV for Predicting PIH in the Elderly
An observational study of Hypotension on Induction, run by Second Xiangya Hospital of Central South University.
Trial summary
The purpose of this observational study is to investigate the predictive power of pulse pressure variability during forced inhalation（PPVfi） on the occurrence of hypotension in elderly patients after induction of general anesthesia. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypotension on Induction
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2025to 15 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Older adult
Study population: Elderly patients without significant moderate to severe systemic comorbidities.
Who may be able to join
- American Society of Anesthesiologists (ASA) classification ≤ Grade III;Age ≥ 65 years old; Elective surgery; Patients who require invasive arterial blood pressure monitoring during surgery.
Who cannot join
- Presence of moderate or severe systemic diseases, such as heart failure, arrhythmias, valvular heart disease, pulmonary hypertension, severe pulmonary diseases (e.g., chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis), endocrine disorders, etc.;Preoperative systolic blood pressure (SBP) ≥160 mmHg, mean arterial pressure (MAP) ≥110 mmHg, or heart rate (HR) ≥120 beats per minute;Patients with comorbid psychiatric or neurological disorders, or communication impairments.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pulse Pressure Variation During Forced Inspiratory Breathing Could Predict Post-Induction Hypotension in Elderly Patients: A Prospective, Observational Study
The purpose of this observational study is to investigate the predictive power of pulse pressure variability during forced inhalation（PPVfi） on the occurrence of hypotension in elderly patients after induction of general anesthesia. The main question it aims to answer is:
Can the PPVfi predict the occurrence of hypotension in elderly patients after induction of general anesthesia? By recording the PPV of patients during forced inhalation before anesthesia induction, with the incidence of hypotension as the state variable and PPV as the test variable, the area under the ROC curve was calculated to determine the optimal threshold, sensitivity, and specificity of PPV.
Read the detailed description
Post-induction hypotension(PIH) usually refers to the hypotension that occurs during the period from anesthesia induction to skin incision, which often occurs during general anesthesia induction. During this period, anesthesiologists may delay the identification and management of hypotension induced by general anesthesia due to their focus on airway management or invasive procedures. Although hypotension usually lasts for a short period of time and can be corrected through fluid replacement and/or medication, there are still studies suggesting that PIH may be associated with adverse postoperative outcomes such as myocardial injury, stroke, and acute kidney injury. Research on predicting PIH both domestically and internationally has focused on evaluating preoperative volume status and autonomic nervous system function. The main indicators for assessing volume responsiveness include pulse pressure variability（PPV）, stroke variability, pulse variability index, perfusion index, etc. Studies have shown that the sensitivity and specificity of pulse pressure variability in identifying PIH are 86% and 86.2%, respectively. In recent years, scholars have proposed that PPV during forced inspiratory breathing (PPVfi) can be used to evaluate patients' volume responsiveness. However, existing research on predicting PIH with pulse pressure variability is mostly focused on middle-aged and young people. However, being over 50 years old is one of the high-risk factors for hypotension after anesthesia induction, and the elderly population has a greater risk of developing hypotension. This study is a non interventional observational prospective study that explores the prediction of hypotension in elderly patients after induction of general anesthesia by exploring the PPV. It helps anesthesiologists to identify and intervene in hypotension after induction of general anesthesia in advance, reducing the occurrence of adverse outcomes after general anesthesia.
- Conditions
- Hypotension on Induction
- Keywords
- Post-induction Hypotension, Pulse Pressure Variation
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Pressure Variation
PPV in tidal and during forced inspiratory breathing
Measured: Before induction
Secondary outcomes (2)
Systolic Pressure Variation
SPV in tidal and during forced inspiratory breathing
Measured: Before induction
blood pressure
SBP、DBP and MAP
Measured: before and after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start5 Sep 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang wenjie, master, Principal investigator, Department of Pain Management, Second Xiangya Hospital, Central South University, Changsha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166562
- Sponsor's protocol ID
- LYF20240327
- Acronym
- PPVfi-PIH
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Pressure Variation During Forced Inspiratory Breathing Could Predict Post-Induction Hypotension in Elderly Patients: A Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07166562
- Acronym / sponsor ID
- PPVfi-PIH / LYF20240327
- Conditions
- Hypotension on Induction
- Keywords
- Post-induction Hypotension, Pulse Pressure Variation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 10 Sep 2025 (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.
The purpose of this observational study is to investigate the predictive power of pulse pressure variability during forced inhalation（PPVfi） on the occurrence of hypotension in elderly patients after induction of general anesthesia. The main question it aims to answer is:
Can the PPVfi predict the occurrence of hypotension in elderly patients after induction of general anesthesia? By recording the PPV of patients during forced inhalation before anesthesia induction, with the incidence of hypotension as the state variable and PPV as the test variable, the area under the ROC curve was calculated to determine the optimal threshold, sensitivity, and specificity of PPV.
Detailed description
Post-induction hypotension(PIH) usually refers to the hypotension that occurs during the period from anesthesia induction to skin incision, which often occurs during general anesthesia induction. During this period, anesthesiologists may delay the identification and management of hypotension induced by general anesthesia due to their focus on airway management or invasive procedures. Although hypotension usually lasts for a short period of time and can be corrected through fluid replacement and/or medication, there are still studies suggesting that PIH may be associated with adverse postoperative outcomes such as myocardial injury, stroke, and acute kidney injury. Research on predicting PIH both domestically and internationally has focused on evaluating preoperative volume status and autonomic nervous system function. The main indicators for assessing volume responsiveness include pulse pressure variability（PPV）, stroke variability, pulse variability index, perfusion index, etc. Studies have shown that the sensitivity and specificity of pulse pressure variability in identifying PIH are 86% and 86.2%, respectively. In recent years, scholars have proposed that PPV during forced inspiratory breathing (PPVfi) can be used to evaluate patients' volume responsiveness. However, existing research on predicting PIH with pulse pressure variability is mostly focused on middle-aged and young people. However, being over 50 years old is one of the high-risk factors for hypotension after anesthesia induction, and the elderly population has a greater risk of developing hypotension. This study is a non interventional observational prospective study that explores the prediction of hypotension in elderly patients after induction of general anesthesia by exploring the PPV. It helps anesthesiologists to identify and intervene in hypotension after induction of general anesthesia in advance, reducing the occurrence of adverse outcomes after general anesthesia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly patients without significant moderate to severe systemic comorbidities.
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) classification ≤ Grade III;Age ≥ 65 years old; Elective surgery; Patients who require invasive arterial blood pressure monitoring during surgery.
Key exclusion criteria (1 listed)
- Presence of moderate or severe systemic diseases, such as heart failure, arrhythmias, valvular heart disease, pulmonary hypertension, severe pulmonary diseases (e.g., chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis), endocrine disorders, etc.;Preoperative systolic blood pressure (SBP) ≥160 mmHg, mean arterial pressure (MAP) ≥110 mmHg, or heart rate (HR) ≥120 beats per minute;Patients with comorbid psychiatric or neurological disorders, or communication impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulse Pressure Variation
Time frame: Before induction
PPV in tidal and during forced inspiratory breathing
2 secondary outcomes
Systolic Pressure Variation
Time frame: Before induction
blood pressure
Time frame: before and after induction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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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.
Zhang wenjie, master principal investigator
Department of Pain Management, Second Xiangya Hospital, Central South University, Changsha
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension on Induction, run by Second Xiangya Hospital of Central South University.
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: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang yaping, phD (13607314476, wangyaping6568@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Pressure Variation (time frame: Before induction). 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 10 Sep 2025.