Elderly Heart Valve SurgerySILENT-HVNCT07710001
Study on Influencing Factors and Intervention of Silent Aspiration After Heart Valve Operation in Elderly Patients
A study testing The intervention was delivered using the Gentle Stim Electrical Stimulation Therapy Device (Model: JC-2071) in people with Elderly Heart Valve Surgery and Silent Aspiration, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly Heart Valve Surgery, Silent Aspiration
- What is being tested?
- The intervention was delivered using the Gentle Stim Electrical Stimulation Therapy Device (Model: JC-2071)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Simple valve surgery
- Age ≥60 years old
- NYHA cardiac function Grade II-III
- ASA Grade II-III
- No dysphagia screened by SSA before surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Elderly Heart Valve Surgery, Silent Aspiration
- Being tested
- The intervention was delivered using the Gentle Stim Electrical Stimulation Therapy Device (Model: JC-2071), Usual Care Group
- Keywords
- Elderly heart valve surgery, Silent aspiration, Interference electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: During the ICU stay, assessed at the time of extubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Feb 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Why it stopped: The study has completed the collection of all target cases as planned, reaching the anticipated sample size. Data collection has ended, and the study has now entered the data cleaning and analysis phase.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Heart Valve SurgeryStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710001
- Sponsor's protocol ID
- 2025KY038
- Acronym
- SILENT-HV
- Status last verified
- Feb 2025
- First submitted
- 10 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Influencing Factors and Intervention of Silent Aspiration After Heart Valve Operation in Elderly Patients
- ClinicalTrials.gov ID
- NCT07710001
- Acronym / sponsor ID
- SILENT-HV / 2025KY038
- Conditions
- Elderly Heart Valve Surgery, Silent Aspiration
- Keywords
- Elderly heart valve surgery, Silent aspiration, Interference electrical stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has completed the collection of all target cases as planned, reaching the anticipated sample size. Data collection has ended, and the study has now entered the data cleaning and analysis phase.
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care and interference with electrical stimulation | Experimental | Device: The intervention was delivered using the Gentle Stim Electrical Stimulation Therapy Device (Model: JC-2071)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. |
| Usual care and blank stimulation | Placebo comparator | Other: Usual Care GroupIn the experimental group, interference electrical stimulation was given on the basis of conventional care, but no current was provided. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Simple valve surgery
- Age ≥60 years old
- NYHA cardiac function Grade II-III
- ASA Grade II-III
- No dysphagia screened by SSA before surgery
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Usual care and interference with electrical stimulation |
| Usual Care GroupA 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. | Other | Usual care and blank stimulation |
Primary outcome
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.
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.
1 secondary outcome
Mechanical Ventilation Duration
Time frame: During the ICU stay, assessed at the time of extubation.
Results and safety
The study was stopped early (reason given: The study has completed the collection of all target cases as planned, reaching the anticipated sample size. Data collection has ended, and the study has now entered the data cleaning and analysis phase.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention was delivered using the Gentle Stim Electrical Stimulation Therapy Device (Model: JC-2071) in people with Elderly Heart Valve Surgery and Silent Aspiration, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study has completed the collection of all target cases as planned, reaching the anticipated sample size. Data collection has ended, and the study has now entered the data cleaning and analysis phase.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.