Safe Use of Speaking Valve in Children During Sleep Using Trans-tracheal Pressure Measurement
Condition: Chronic Lung Disease of Prematurity; Chronic Respiratory Failure
MeSH terms: Lung Diseases; Respiratory Insufficiency; Bronchopulmonary Dysplasia
Study type: Observational

Summary: 
      Many children who are born medically fragile due to prematurity, multiple congenital
      abnormalities or an acquired insult (i.e. cardiac, neurologic, etc.) may require tracheostomy
      tube placement due to need of chronic respiratory support. Patients on tracheostomy tubes are
      often unable to vocalize, causing a delay in speech development and poor speech. To help
      restore normal phonation and promote language development in young pediatric patients with
      tracheostomies, speaking valves are used. Previously it was shown that the Passy-Muir
      speaking valve was safe to use during sleep in children by showing there were no adverse
      cardiopulmonary events seen. One objective measurement that was not evaluated was
      trans-tracheal pressure manometry. The purpose of this study is to continue to validate the
      safety of the Passy-Muir speaking valve while asleep, with the use of trans-tracheal
      manometry by comparing expiratory pressure manometry while the patient is awake and asleep.
    

Detailed description: 
      Previously it was shown that the Passy-Muir speaking valve was safe to use during sleep in
      children. There were no adverse cardiopulmonary events seen while wearing the speaking valve
      during sleep. However, trans-tracheal pressure was not measured while these children were
      asleep wearing the Passy-Muir speaking valve.The investigators hypothesize that patients who
      tolerate speaking valve while awake will have similar trans-tracheal pressure measurement
      when asleep as when they are awake.

      The specific aims of this proposal are:

      1) to show that the Passy-Muir speaking valve worn during sleep has similar trans-tracheal
      pressure manometry as when worn while awake.

      The primary outcome measure is to show that trans-tracheal manometry measurement is similar
      while on the Passy-Muir speaking valve when patients are awake and asleep

      Secondary outcomes are a) recording of symptoms (i.e. choking, gagging, increased respiratory
      rate, abnormal breathing pattern, coughing, chest tightness and aversion) while wearing the
      speaking valve either awake or asleep b) recording vital signs which will be compared to
      normal and baseline for age (i.e. heart rate, respiratory rate, end-tidal carbon dioxide and
      oxygen saturation) while awake and asleep.

      Background and significance:

      Previously it was shown that Passy-Muir speaking valve is safe to use during sleep in
      children. However it continues to be contraindicated for use while asleep. A small
      prospective study done on 10 tracheostomized adult patients with a mean age of 70 years
      showed that the use of the speaking valve for one night in seriously ill patients was not
      associated with apneas or significant desaturations. A cohort study of 32 tracheostomized
      patients showed that 14 patients were able to tolerate speaking valve for 24 hours; even
      during sleep.

      Pediatric patients with tracheostomy tube are often unable to vocalize. Tracheostomy tubes
      allow the exhaled flow of air to bypass the vocal cords out through the opening of the tube
      making speech difficult. This causes a delay in speech development and poor speech. Speaking
      valves, like the Passy-Muir valve, restore normal phonation and promote language development
      in young pediatric patients with tracheostomies. Speech development is not the only benefit
      seen with speaking valves. Speaking valves can lead to improvement in swallowing safety
      reducing aspiration, improved ventilator weaning leading to more rapid tracheal
      decannulation, reduce secretion management, improve hygiene, and enhance smell and taste.

      Evaluation of speaking valve tolerance can be done by monitoring vital signs (i.e.
      respiratory rate, heart rate, and oxygen saturation). In addition, measurement of
      trans-tracheal pressure is an invaluable tool in evaluating subjects for speaking valve
      placement. Measurement of trans-tracheal pressure is predictive of good tolerance of the
      valve.

      The measurement allows one to quickly and easily assess patency of the upper airway and the
      ability to force air through the vocal cords. If the pressures are elevated, greater than 10
      cm of water on inhalation phase and 30cm of water on the exhalation phase, it would indicate
      an obstruction in the upper part of the trachea (i.e. subglottic stenosis). The pressures can
      also evaluate respiratory function prior to considering patients for placement of the valve.

      Many children who are born medically fragile due to prematurity, multiple congenital
      abnormalities or an acquired insult (i.e. cardiac, neurologic, etc.) may require tracheostomy
      tube placement due to need of chronic respiratory support. Initially, after a patient is
      assessed for a speaking valve and is cleared for use, a patient may be apprehensive toward
      the speaking valve.

      If a patient displays discomfort, anxiety, dyspnea/respiratory distress or there is air
      trapping (from the build-up of subglottic pressure from incomplete exhalation) trials are
      repeated on subsequent days. However, one can assume that initial failure is due to aversion,
      but it may be due to resistance in the upper airway, or vice versa.

      The purpose of this study is to continue to validate the safety of the Passy-Muir speaking
      valve while asleep, with the use of trans-tracheal manometry by comparing expiratory pressure
      manometry while the patient is awake and asleep.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Number of Subjects: The current number of subjects at St Mary's Healthcare System for
        Children approved and tolerates the Passy-Muir speaking valve are eight. All eight children
        will be recruited for the study.

        Gender of Subjects: Both males and females subjects will be eligible for this study

        Age of Subjects: Children ages 0-18 yrs old.

        Racial and Ethnic Origin: All races and ethnic origins will be eligible for this study