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

16. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

117

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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 komparator: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
α-Amylase Level in Airway Secretions
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mechanical Ventilation Duration
Tidsramme: 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.

Samarbejdspartnere og efterforskere

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Sponsor

Fujian Medical University Union Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2025

Primær færdiggørelse (Faktiske)

31. januar 2026

Studieafslutning (Faktiske)

31. januar 2026

Datoer for studieregistrering

Først indsendt

10. juli 2026

Først indsendt, der opfyldte QC-kriterier

16. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. februar 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2025KY038

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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