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

NCT07710001 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2026-07-17

No results posted yet for this study

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.

Conditions

  • Elderly Heart Valve Surgery
  • Silent Aspiration

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.

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07710001 on ClinicalTrials.gov