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Introduction

Tracheostomy has become an increasingly common procedure performed in pediatric patients. Indications for tracheostomy have changed in recent years and include upper airway obstruction secondary to congenital birth anomalies or acquired anatomic abnormalities such as subglottic stenosis, and anticipated need for prolonged ventilation . Currently, the most common indication is prolonged need for ventilation due to neuromuscular diseases or respiratory conditions such as chronic lung disease . The most common pediatric age group in which this procedure is performed is under 1 year of age , probably due to increased survival of preterm infants . (See Figs. 1 and 2 .)

Airflow pathway during breathing when valve is attached to external opening of tracheostomy (included with permission of Passy-Muir Inc).

The “no leak” position of the tracheostomy-speaking valve versus other valve with a leak (included with permission of Passy-Muir Inc.).

A tracheostomy-speaking valve (TSV) is a one way valve that attaches to the outside opening of the tracheostomy tube. When the patient inhales, the valve opens to let air flow through the tracheostomy tube and into the lungs. During exhalation, the valve closes without a leak and the air is directed around the tracheostomy tube and through the vocal cords, larynx, oral and nasal cavities, enabling speech. The closed position of the valve allows for a normal uninterrupted respiratory system which in turn allows for generation of positive subglottic pressure. Exhaling around the tracheostomy tube is harder than through it, and some children may need time to adapt and build the strength and ability to do this.

The literature is scant regarding the use of speaking valves in children and infants. Passy et al. evaluated the efficacy of a one-way speaking valve in 15 adult ventilator-dependent patients. They concluded that the TSV is a safe and effective adjunct to ventilator-dependent patients in improving communication skills, speech flow and volume .

The goal of using a speaking valve in children with tracheostomy is to provide early vocalization practice and to enable speech production. A retrospective review of 64 charts examined the documented evidence of tolerance of the TSV in infants and children younger than 2 years of life. 83% of these children tolerated the TSV and 75% produced vocalization on their first trial . A later retrospective study in 55 tracheostimized children, infants to 18 years, concluded that many of them (95%) tolerated the TSV. The subjects may have needed 2 or more trials with the TSV until the patient and family were comfortable with it. The most common reasons for failure in the TSV trials were inadequate leak around the tracheostomy tube, childhood behavioral problems related to the placement of the valve, limited parental behavioral management skills or parental problems with the TSV care and use, and inadequate pulmonary toilet once the valve was placed .

Having a tracheostomy predisposes the patient to aspiration due to reduced laryngeal elevation, reduced cough effectiveness, relative esophageal obstruction, disruption of phasic glottis function and blunting of glottis closure reflex (resulting in loss of proprioception) . In addition to its use for vocalization, studies have shown that the use of TSV may decrease the risk of aspiration . The TSV seams to ameliorate some of these adverse effects of the tracheostomy tube.

Another possible benefit of using the TSV is that it decreases the respiratory secretions in tracheostomized patients. Lichtman et al. studied 8 adult patients and found a significant decrease in respiratory secretions when wearing the TSV. This study demonstrated a reduction in the collected secretions by manual suctioning. The mechanism is unknown, but the authors hypothesize that the secretion reduction is a result of the redirection of airflow to the oral and nasal passages, causing evaporation of secretions in these pathways. They also found an improvement in olfaction with the use of the TSV .

Lastly, the use of TSV was shown to decrease the time to decannulation. Le et al. examined 10 adult patients and compared the rate of successful decannulation using conventional cap versus one-way valve. They revealed that the time to decannulation was slightly shorter with the use of one-way valve (median 18 days) compared to conventional capping (median 23 days). However, this difference did not achieve statistical significance due to the small number of patients enrolled in the study .

Currently, the TSV are FDA approved to be used only during the daytime while the patient is awake. There is scant data on TSV safety during sleep. To our knowledge there are no studies published that address the safety of the TSV use during sleep in children. As the valve has multiple advantages, in this study we aim to assess the safety of TSV use in children during sleep.