Study on Influencing Factors and Intervention of Silent Aspiration After Heart Valve Operation in Elderly Patients (SILENT-HV)
16 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
117
Fas
- Inte tillämpbar
Kontakter och platser
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Studieorter
-
-
Fujian
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Fuzhou, Fujian, Kina, 350000
- Fujian Medical University Union Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
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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.
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Placebo-jämförare: 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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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α-Amylase Level in Airway Secretions
Tidsram: 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.
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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.
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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.
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Pepsin Level in Airway Secretions
Tidsram: 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.
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Pepsin level in airway secretions was measured as a biomarker for silent aspiration.
A level >200 ng/ml was considered positive for silent aspiration.
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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.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mechanical Ventilation Duration
Tidsram: During the ICU stay, assessed at the time of extubation.
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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.
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During the ICU stay, assessed at the time of extubation.
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Studieavstämningsdatum
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Studera stora datum
Studiestart (Faktisk)
1 februari 2025
Primärt slutförande (Faktisk)
31 januari 2026
Avslutad studie (Faktisk)
31 januari 2026
Studieregistreringsdatum
Först inskickad
10 juli 2026
Först inskickad som uppfyllde QC-kriterierna
16 juli 2026
Första postat (Faktisk)
17 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2026
Senast verifierad
1 februari 2025
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2025KY038
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