SESSION TITLE: Pediatric Critical Care Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM
PURPOSE: There are different medical reasons why children receive a tracheostomy tube and it is known that its presence can cause speech delay. The Passy-Muir Tracheostomy-Speaking Valve (PMSV) was designed to allow verbal communication for patients with tracheostomy tubes. PMSV is a one-way valve that attaches to the tracheostomy and assists in redirecting the air flow through the upper airway resulting in phonation. PMSV also improves swallowing, oxygenation, respiratory secretion management, and expedites decannulation. The use of PMSV is only approved by FDA for use during wake hours. The aim of this study was to evaluate the safety of PMSV overnight so these children can benefit from its advantages during sleep.
METHODS: This clinical trial was approved both by FDA and IRB. Inpatients from St Mary’s Hospital, ages 1 to 18 years, with a tracheostomy tube who were using a PMSV during daytime/awake period were included in the study. The subjects had baseline records of heart rate (HR), respiratory rate (RR), oxygen saturation (HbO2), and end tidal carbon dioxide (ETCO2) the night prior to the study night at scheduled times throughout the night. PMSV was placed the following night, and the same parameters were recorded (study night).
RESULTS: A total of 7 patients were recruited with the age range of 2 years to 11 years. The mean of the parameters pre and post intervention in all subjects showed no significant clinical changes between baseline and the study night. Repeated measure ANOVA analysis did not reveal any significant differences in the HR, RR, HbO2 and ETCO2 between the preintervention night and study night. No major adverse events were recorded during the study night.
CONCLUSIONS: This pilot study showed that extended use of PMSV while the child is asleep was not associated with adverse cardiopulmonary events. The limitation of this study is that it has a small cohort of patients
CLINICAL IMPLICATIONS: This is the first study to show that a speaking valve can be used safely during sleep.
DISCLOSURE: The following authors have nothing to disclose: Giselle Barraza, Claudia Halaby, Shahidul Islam, William Gutekunst, Edwin Simpser, Melodi Pirzada
The Passy Muir speaking valve is only approved for day time use by FDA. It is not approved for night time use.