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Safe Use of Speaking Valve in Children During Sleep Using Trans-tracheal Pressure Measurement

NCT02935140 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2016-11-21

No results posted yet for this study

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.

Conditions

  • Chronic Lung Disease of Prematurity
  • Chronic Respiratory Failure

Sponsors & Collaborators

  • St Mary's Hospital for Children

    lead OTHER

Principal Investigators

  • Melodi Pirzada, MD · St Mary's Healthcare System for Children

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-06-30
Completion
2016-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02935140 on ClinicalTrials.gov