Predicting the Clinical Advantages of Speaking Valves Through Wearable Devices
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:
- Breathing is steady at rest: no apparent dyspnea, chest tightness, or orthopnea, etc.
- Heart rate, blood pressure, and SpO₂ are all stable overall.SpO₂ reduction from baseline < 5%.
- No frequent need for emergency sputum suction or indications of sputum blockage while wearing it.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100144
- Beijing Rehabilitation Hospital, Capital Medical University
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Successfully wore the speaking valve for the first time for 30 minutes.
Inclusion Criteria：
|
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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
degree of change in oxygen saturation（%）
時間枠：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).
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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.
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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).
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Temporal rate of change of asymmetric cardiovascular responses and delayed autonomic recovery（percentage change from baseline）
時間枠：30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
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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
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30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
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Rate of respiratory phase variation during training（percentage change in phase duration）
時間枠：30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
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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.
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30 minutes before speaking valve placement, throughout the entire training session (i.e., during valve wear), and 30 minutes after the training session
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Hongying Jiang、Beijing Rehabilitation Hospital of Capital Medical University, Beijing, China
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2026-bjkfyy-SVB
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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