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TERMINATED
NCT07710001
NA

Study on Influencing Factors and Intervention of Silent Aspiration After Heart Valve Operation in Elderly Patients

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

Summary

Objective To investigate the safety and effectiveness of interference electrical stimulation in the prevention of silent aspiration after heart valve surgery in elderly patients. Silent aspiration was diagnosed when either pepsin level \>200 ng/ml or α-amylase level \>1685 U/L was detected in airway secretions.

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

117

Start Date

2025-02-01

Completion Date

2026-01-31

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DEVICE

The intervention was delivered using the Gentle Stim Electrical Stimulation Therapy Device (Model: JC-2071)

Prior to the intervention, the patient's skin was inspected for symptoms such as redness, swelling, or ulceration, and cleansed with an alcohol swab. The leads of the Gentle Stim electrical stimulation therapy device were checked to ensure they were safe and unobstructed. After resetting all settings to zero, the device was switched on. Electrode pads were attached, with two pairs of electrodes placed on the upper and lower lateral aspects of the thyroid cartilage, spaced 4 cm apart, and properly secured. The stimulation intensity was adjusted: one pair of electrodes was set to an output of 2050 Hz, and the other pair to 2000 Hz. The current was set between 2 and 2.5 mA.

OTHER

Usual Care Group

A sham intervention was performed using the Gentle Stim electrical stimulation therapy device. The device was applied identically to the experimental group but without delivering any electrical current. The wearing duration was consistent with that of the experimental group.

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China