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Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices

5 août 2026 mis à jour par: Bin Zhang

Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices:A Prospective Cohort Study

The population included in this study consists of tracheostomy patients admitted to the pulmonary department of Beijing Rehabilitation Hospital, undergoing decannulation rehabilitation treatment. Once patient conditions stabilized, they were all transitioned to the decannulation process established by our department in 2018, which utilizes a speaking valve instead of capping.The initial duration for the patient to wear the speaking valve is 30 minutes.The monitoring period for wearable devices is from 1 hour before the initial use of the speaking valve to 1 hour after its removal.Monitored for a total of 2 hours and 30 minutes.Explore the clinical benefits of the speaking valve by comparing the changes in patients' physiological parameters and clinical index metrics before and after using the speaking valve.

Criteria for the successful use of the speaking valve for 30 minutes:

  1. Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc.
  2. Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline < 5%.
  3. No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

120

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100144
        • Beijing Rehabilitation Hospital, Capital Medical University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • 90 years≥Age≥18 years;
  • Tracheotomy post-operation>48 hours；
  • Weaned off mechanical ventilation;
  • Clinically stable condition;
  • Tolerable for cuff deflation;
  • Able to tolerate wearing a speaking valve continuously for 30 minutes;
  • Signed informed consent.

Exclusion Criteria:

  • Patients with abnormal skin conditions preventing continuous wearing of monitoring devices;
  • Inability to tolerate wearing a speaking valve continuously for 30 minutes;
  • Interruption of physiological monitoring data;
  • Poor quality of physiological monitoring data;
  • Recently underwent neck/upper airway surgery (≤48 hours, to avoid airflow impact on the upper airway);
  • Severe consciousness disturbance/delirium (RASS score≤-3 or ≥ +2), extreme anxiety/uncooperativeness;
  • Total laryngectomy or laryngotracheal separation;
  • Age <18 years or >90 years;
  • Malignant tumor with an expected survival time ≤6 months;
  • The patient or legal representative is unable to sign the informed consent form.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Successfully wore the speaking valve for the first time for 30 minutes.

Inclusion Criteria：

  1. Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc.
  2. Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline < 5%.
  3. No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.
Autre: Tracheostomy patients who are able to tolerate wearing a speaking valve for 30 minutes

Once patient conditions stabilized, they were all transitioned to the decannulation process established by our department in 2018, which utilizes a speaking valve instead of capping.The initial duration for the patient to wear the speaking valve is 30 minutes.If the patient can tolerate wearing the speaking valve for 30 minutes, they fulfill the inclusion criteria.The monitoring period for wearable devices is from 1 hour before the initial use of the speaking valve to 1 hour after its removal.Monitored for a total of 2 hours and 30 minutes.

Physiological parameters recorded prior to wearing the speaking valve served as the baseline.Compare the physiological parameters while wearing the speaking valve and after its removal to investigate the clinical benefits that the speaking valve can provide.To promote the application of speaking valves in future clinical work more effectively

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
degree of change in oxygen saturation（%）
Délai: Using wearable biosensors, high-resolution physiological data were continuously collected during three phases: baseline (30 minutes), speaking valve placement period (30 minutes), and recovery period (30 minutes after speaking valve removal).
Previous studies have been concerned that speaking valve placement increases upper airway resistance, thereby inducing dyspnea and hypoxemia in patients. Therefore, we used continuous wearable physiological monitoring devices to observe changes in oxygen saturation before, during, and after the training.
Using wearable biosensors, high-resolution physiological data were continuously collected during three phases: baseline (30 minutes), speaking valve placement period (30 minutes), and recovery period (30 minutes after speaking valve removal).
Temporal rate of change of asymmetric cardiovascular responses and delayed autonomic recovery（percentage change from baseline）
Délai: 30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
The rate of change (percentage per minute) in asymmetric cardiovascular responses (e.g., heart rate variability indices) and delayed autonomic recovery will be calculated. Physiological data (heart rate, HRV metrics) are continuously collected before, during, and after speaking valve placement. The primary reported value is the slope of change over time, expressed as a percentage relative to baseline, aggregated across all participants using mixed-effects modeling to produce a single mean rate of change
30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
Rate of respiratory phase variation during training（percentage change in phase duration）
Délai: 30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
The rate of change in respiratory phase variation (e.g., changes in inspiratory/expiratory time proportion) during speaking valve training. Respiratory parameters are continuously recorded. The outcome is the calculated rate of change (percentage per minute) from baseline to the active training period and to the recovery period. A single aggregated value (mean slope) will be derived from all participants using linear mixed models.
30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bin Zhang

Collaborateurs

Chinese PLA General Hospital
Capital Medical University

Les enquêteurs

  • Chaise d'étude: Hongying Jiang, Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 avril 2026

Achèvement primaire (Réel)

30 juillet 2026

Achèvement de l'étude (Réel)

31 juillet 2026

Dates d'inscription aux études

Première soumission

27 février 2026

Première soumission répondant aux critères de contrôle qualité

11 mai 2026

Première publication (Réel)

14 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 août 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 2026-bjkfyy-SVB

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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