To the Editor

Tracheostomy is a surgical procedure commonly performed in the intensive care unit (ICU) [1]. It creates an artificial opening in the trachea for prolonged ventilation or airway obstruction. It offers benefits like improved airway protection and decreased respiratory effort but also brings physiological and psychological challenges, including speech loss and anxiety [2]. A speaking valve, attached to the tracheostomy tube, allows speech and improves swallowing, reduces aspiration risk, and enhances lung mechanics [3]. Early use improves patient activity and mobility, alleviating anxiety, depression, and social isolation [4, 5].

Despite many clinical benefits of speaking valves, their widespread use in clinical practice is still limited in many countries, including China [6]. The safety of speaking valve was not fully studied. This study aimed to determine the utility and safety of speaking valves in tracheostomy patients, facilitating evidence-based clinical use of speaking valves.

This study was approved by the Ethics Committee of Beijing Rehabilitation Hospital, Capital Medical University (approval number: 2017bkky066), and all participants provided written informed consents. Patients with tracheostomy receiving speaking valves at the Department of Respiratory and Critical Care Medicine, Beijing Rehabilitation Hospital, between September 2017 and September 2021 were included. The inclusion criteria were: (1) patients who had been successfully weaned off mechanical ventilation, (2) first-time use of a speaking valve, and (3) Glasgow Coma Scale (GCS) score ≥ 9. Patients were excluded from the study if: (1) altered mental status, (2) severe cognitive impairment, (3) unstable clinical condition, (4) severe upper airway obstruction, (5) excessive and thick airway secretions, (6) incompatibility between the speaking valve and tracheostomy tube.

Before placement, suctioning of airway and oral secretions was performed. The cuff was deflated and the valve secured. Vital signs and respiratory status were monitored, and the valve removed if distress occurred. We assessed patients’ vital signs, breath sounds, and secretions before, during, and after placement, recording tolerance, duration of use, reasons for discontinuation, and other variables. Descriptive statistics summarized patient characteristics and outcomes.

A total of 120 patients met the inclusion and exclusion criteria (male:female, 85:35). The age of the patients ranged from 14 to 93 years, with a mean age of 64.3 years. The average APACHE II score at admission was 12.1 ± 6, and the duration of tracheostomy ranged from 0 to 455 days, with an average of 66.0 days.

The interval between tracheostomy and the first placement of the speaking valve ranged from 7 to 455 days, with an average of 69.8 days. Among the patients, 37 (36.3%) tolerated the first-time use of the speaking valve well, However, 65 patients (63.7%) experienced poor tolerance, with a duration of use ranging from 1 to 47 min and an average duration of 13.2 min.

The reasons for poor tolerance were summarized in Table 1, included coughing, respiratory difficulty, decreased oxygen saturation, and fatigue. The interval between the first-time use of the speaking valve and successful decannulation ranged from 3 to 425 days, with an average of 47.0 days.

During the entire study period, one adverse event occurred. A patient’s family mistakenly inflated the speaking valve, thinking it was a heat and moisture exchanger, leading to choking and a decrease in blood oxygen saturation. With medical monitoring, the incident was promptly detected by the hospital staff and did not result in severe adverse events.

Tube occlusion is a traditional method for assessing upper airway patency, but some patients may not tolerate it. The speaking valve allows airflow through the vocal cords during exhalation, indicating upper airway patency if worn continuously for ≥ 12 h. In this study, 65 patients had poor tolerance to initial wearing, and 20 during training. Poor tolerance may indicate upper airway obstruction, restricted airflow, aspiration, or weakness,repeated evaluations are necessary due to variable and potentially dangerous conditions. Two patients initially tolerated the valve but later showed poor tolerance due to vocal cord paralysis. Speaking valves have benefits but clinical application requires caution due to potential life-threatening risks [7]. Common issues in tracheostomy patients include difficulty breathing, decreased oxygen saturation, coughing (36.3% prevalent as showed in our study), fatigue, and impaired speech [8]. Coughing can be triggered by the reintroduction of airflow, secretion accumulation, and should be managed by removing the valve, suctioning, and checking for airway obstruction. Two cases in this study had the valve pop out but were successfully decannulated.

In this study, 25 patients had difficulty breathing with the speaking valve. Reassessment for cuff deflation, tube size, and airway obstruction was necessary [9]. Considerations included anxiety relief through patient education, and breathing pattern retraining using distracting techniques, visual biofeedback, and task-oriented approaches. Of these patients, 20 eventually tolerated the valve and were successfully decannulated.

Decrease in blood oxygen saturation when wearing a speaking valve in tracheostomy patients may indicate upper airway obstruction or excessive airway secretions [10]. Secretions should be cleared and suctioning performed. If the valve is not tolerated, temporary suspension and measures such as airway clearance training, speech and swallowing therapy, enhanced positioning, and pharmacological treatments may be necessary. In this study, 13 patients with excessive secretions were successfully decannulated after ear patches or botulinum toxin injections.

Some tracheostomy patients experience impaired speech after wearing a speaking valve,causes include upper airway damage, inadequate expiratory peak flow, and vocal cord dysfunction [11]. Respiratory muscle training and lung capacity increase can help. A “trumpet” sound may occur due to the valve and can be resolved by cleaning or replacing it. In this study, 4 patients had this issue resolved by replacing the valve.

One patient’s family mistakenly inflated the cuff. Subsequently, we implemented the practice of affixing warning labels to the cuff inflation tube, effectively preventing the occurrence of such adverse events.

In conclusion, speaking valves can be used in mechanically ventilated patients to assess and manage airway functions before and during weaning. Wearing a speaking valve in tracheostomy patients prevents speech impairment and assesses upper airway integrity. With proper procedures and monitoring, its clinical application is safe and worthy of widespread adoption.

No datasets were generated or analysed during the current study.

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Authors and Affiliations

1. Beijing Rehabilitation Hospital, Capital Medical University, Beijing, China

   Hao Wang

2. Department of Pulmonary and Critical Care Medicine, Beijing Rehabilitation Hospital, Capital Medical University, Xixiazhuang, Badachu Road, Shijingshan District, Beijing, 100144, China

   Hongying Jiang & Chenxi Zhang

3. School of Biomedical Engineering, Guangzhou Medical University, Guangzhou, China

   Zhanqi Zhao

4. Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, 9500 Eulcid Ave, Cleveland, OH, 44195, USA

   Jia Liu

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Contributions

Conceptualization; Data curation; Methodology; Writing–original draft: Hao Wang, Beijing Rehabilitation Hospital, Capital Medical University, China Validation; prepared Table 1: Hongying Jiang, Department of Pulmonary and Critical Care Medicine, Beijing Rehabilitation Hospital, Capital Medical University, China Validation; prepared Table 1: Zhanqi Zhao, School of Biomedical Engineering, Guangzhou Medical University, China Writing–review & editing:Jia Liu Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, 9500 Eulcid Ave Cleveland Ohio 44,195, America Writing–review & editing: Chenxi Zhang, Department of Pulmonary and Critical Care Medicine, Beijing Rehabilitation Hospital, Capital Medical University, China.

Corresponding authors

Correspondence to Jia Liu or Chenxi Zhang.

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The authors declare no competing interests.

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Wang, H., Jiang, H., Zhao, Z. et al. Application and safety of speaking valves in tracheostomy patients. Crit Care 28, 424 (2024). https://doi.org/10.1186/s13054-024-05217-2

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• Received: 08 December 2024

• Accepted: 14 December 2024

• Published: 18 December 2024

• DOI: https://doi.org/10.1186/s13054-024-05217-2

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