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

NCT07710001 | Terminated

• 1 other identifier: 2025KY038
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Elderly heart valve surgery; Silent aspiration; Interference electrical stimulation

Outcome Measures

Primary Outcomes (2)

• α-Amylase Level in Airway Secretions

  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

  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 Outcomes (1)

• Mechanical Ventilation Duration

  During the ICU stay, assessed at the time of extubation.

Study Arms (2)

Usual care and interference with electrical stimulation

EXPERIMENTAL

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)

Usual care and blank stimulation

PLACEBO COMPARATOR

In the experimental group, interference electrical stimulation was given on the basis of conventional care, but no current was provided.

Other: Usual Care Group

Interventions

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

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.

Usual care and interference with electrical stimulation

Usual Care Group OTHER

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.

Usual care and blank stimulation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 17, 2026
• Study Start: February 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: July 17, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)