Study on Influencing Factors and Intervention of Silent Aspiration After Heart Valve Operation in Elderly Patients (SILENT-HV)

July 16, 2026 updated by: Fujian Medical University Union Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this study, a randomized controlled trial was conducted in elderly patients undergoing heart valve surgery at Fujian Medical University Union Hospital. Patients were selected according to the inclusion and exclusion criteria and randomly allocated to either the experimental group (routine nursing + interference electrical stimulation) or the control group (routine nursing + blank stimulation). Silent aspiration was diagnosed when either pepsin level >200 ng/ml or α-amylase level >1685 U/L was detected in airway secretions. Airway secretions were collected upon ICU admission after surgery, every 12 hours thereafter (depending on endotracheal tube indwelling time), before extubation, 24 hours after extubation, and on day 6 after surgery. The incidence of silent aspiration, swallowing function, clinical pulmonary infection score, mechanical ventilation duration, ICU length of stay, total hospital stay, and adverse events were compared between the two groups.

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Fujian Medical University Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Simple valve surgery
  • Age ≥60 years old
  • NYHA cardiac function Grade II-III
  • ASA Grade II-III
  • No dysphagia screened by SSA before surgery

Exclusion Criteria:

  • Vocal cord dysfunction, oropharyngeal malignancies, or neck surgery affecting swallowing function
  • Postoperative hemodynamic instability and active bleeding
  • COPD, asthma, chronic bronchitis, lung cancer or other respiratory diseases
  • Previous gastroesophageal reflux disease
  • Serious mental or neurological disease
  • Skin damage or electrode allergy at the stimulation site
  • Implanted cardiac pacemaker
  • Participation in other interventional studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Usual care and interference with electrical stimulation
In order to reduce the incidence of silent aspiration, interference electrical stimulation was performed in elderly patients after valve operation. Interference electrical stimulation can stimulate the afferent nerve deeper in the pharynx and larynx, enhance the ability of airway protection, and increase the frequency of swallowing, reduce the occurrence of silent aspiration. This measure is non-invasive and safe, and the side effect is only itchy skin caused by an allergic electrode.
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.
Placebo Comparator: Usual care and blank stimulation
In the experimental group, interference electrical stimulation was given on the basis of conventional care, but no current was provided.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
α-Amylase Level in Airway Secretions
Time Frame: Upon admission to ICU after surgery, every 12 hours thereafter (depending on endotracheal catheter indwelling time), before extubation, 24 hours after extubation, 6 days after surgery.
α-Amylase level in airway secretions was measured as a biomarker for silent aspiration. A level >1685 U/L was considered positive for silent aspiration.
Upon admission to ICU after surgery, every 12 hours thereafter (depending on endotracheal catheter indwelling time), before extubation, 24 hours after extubation, 6 days after surgery.
Pepsin Level in Airway Secretions
Time Frame: Upon admission to ICU after surgery, every 12 hours thereafter (depending on endotracheal catheter indwelling time), before extubation, 24 hours after extubation, 6 days after surgery.
Pepsin level in airway secretions was measured as a biomarker for silent aspiration. A level >200 ng/ml was considered positive for silent aspiration.
Upon admission to ICU after surgery, every 12 hours thereafter (depending on endotracheal catheter indwelling time), before extubation, 24 hours after extubation, 6 days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical Ventilation Duration
Time Frame: During the ICU stay, assessed at the time of extubation.
Total duration of postoperative mechanical ventilation, measured in hours, from the time of ICU admission after surgery (initiation of mechanical ventilation) to the time of successful extubation.
During the ICU stay, assessed at the time of extubation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

January 31, 2026

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

July 10, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025KY038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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