NCT05628051

Brief Summary

The number of elderly patients undergoing elective surgery has been growing in recent years. Elderly patients often have a variety of underlying diseases, including hypertension, coronary heart disease, diabetes, arteriosclerosis, etc., which increase the risk. When the elderly receive general anesthesia, hypotension often occurs after anesthesia induction. Once hypotension occurs, it may lead to myocardial ischemia, myocardial infarction, stroke and other serious complications. Therefore, in clinical anesthesia, a simple, quick and accurate prediction method is needed to evaluate and predict the risk of hypotension in elderly patients after induction, so that appropriate intervention measures can be taken in advance to reduce the incidence of hypotension in elderly patients after induction, thus reducing the occurrence of related complications and ensuring the safety of anesthesia and surgery.Carotid Artery Corrected Flow Time(FTc) is a recently developed volumetric predictor, which refers to the time between the the onset of systolic flow until the closure of the aortic valve. It is related to cardiac preload and can reflect cardiac output to a certain extent. It is considered as a reliable indicator for evaluating volume status and volumetric reactivity. Therefore, this study assessed the effect of FTc combined with perioperative fluid therapy on preventing hypotension after general anesthesia induction in elderly patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

November 17, 2022

Last Update Submit

October 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Carotid artery corrected flow time (FTc)

    the area under the receiver operating characteristics curve of corrected flow time in carotid artery measured by ultrasonography to predict hypotension after anesthetic induction

    5 minutes before induction of general anesthesia

Study Arms (2)

Hypotension after anesthetic induction group

Patients with hypotension after anesthetic induction

Procedure: ultrasonographic measurement of carotid artery corrected flow time (FTc)

Non-hypotension after anesthetic induction group

Patients without hypotension after anesthetic induction

Procedure: ultrasonographic measurement of carotid artery corrected flow time (FTc)

Interventions

Ultrasonic measurement of carotid corrected blood flow time: 1. Patient's head turned to the left 30°. Firstly, the 6.0 \~ 13.0MHz linear probe was placed longitudinally on the maternal neck, and the probe marker was oriented towards the maternal head. Real-time B-ultrasound images of the long axis of the right common carotid artery were obtained from the lower margin of the thyroid cartilage. Then, the probe was placed in the center of the carotid lumen, about 2cm from the bifurcation of the carotid artery, to obtain the arterial pulse Doppler flow spectrum and store the carotid flow waveform. 2. Using the caliper function of the ultrasonic instrument, carotid flow time (FT) was obtained by measuring the interval between the systolic ascending stage and the restroke notch. Wodey (W) formula to calculate FTc. FTc= FT+\[1.29× (HR-60)

Hypotension after anesthetic induction groupNon-hypotension after anesthetic induction group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were scheduled to undergo elective surgery under general anesthesia

You may qualify if:

  • patients who received elective surgery under general anesthesia, aged 65-85 years old, gender unlimited, ASAI-II

You may not qualify if:

  • uncontrolled hypertension
  • unstable angina pectoris
  • history of myocardial infarction
  • after heart stent implantation
  • severe arrhythmia:Atrial fibrillation、Ventricular premature beat, frequent atrial premature beat, other non-sinus rhythm
  • pacemaker implants
  • cardiomyopathy
  • a left ventricular ejection fraction of \< 40%
  • history of neck trauma and surgery
  • BMI\>30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Related Publications (1)

  • Huang S, Liao Z, Chen A, Wang J, Xu X, Zhang L. Effect of carotid corrected flow time combined with perioperative fluid therapy on preventing hypotension after general anesthesia induction in elderly patients: a prospective cohort study. Int J Surg. 2024 Feb 1;110(2):799-809. doi: 10.1097/JS9.0000000000000863.

Study Design

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

Study Record Dates

First Submitted

November 17, 2022

First Posted

November 28, 2022

Study Start

June 1, 2022

Primary Completion

December 30, 2022

Study Completion

March 1, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations