NCT07166562

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

September 5, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 3, 2025

Last Update Submit

September 3, 2025

Conditions

Keywords

Post-induction HypotensionPulse Pressure Variation

Outcome Measures

Primary Outcomes (1)

  • Pulse Pressure Variation

    PPV in tidal and during forced inspiratory breathing

    Before induction

Secondary Outcomes (2)

  • Systolic Pressure Variation

    Before induction

  • blood pressure

    before and after induction

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients without significant moderate to severe systemic comorbidities.

You may qualify if:

  • American Society of Anesthesiologists (ASA) classification ≤ Grade III;Age ≥ 65 years old; Elective surgery; Patients who require invasive arterial blood pressure monitoring during surgery.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Zhang wenjie, master

    Department of Pain Management, Second Xiangya Hospital, Central South University, Changsha

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 10, 2025

Study Start

September 5, 2025

Primary Completion

October 30, 2025

Study Completion

November 15, 2025

Last Updated

September 10, 2025

Record last verified: 2025-09