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

NCT02935140 | Completed

• 1 other identifier: 2015-09
• Study Type: observational
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Trans-tracheal Pressure Measurement

  trans-tracheal manometry measurement is similar while on the Passy-Muir speaking valve when patients are awake and asleep

  one day

Secondary Outcomes (2)

• Recording of symptoms

  one day

• vital signs

  one day

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• i. Any subject between the ages of 0-18 years of age who is a resident of St Mary's Healthcare System for Children with a chronic tracheostomy may be enrolled. Patients have to be approved for a Passy-Muir speaking valve as per St Mary's Healthcare System for Children written policy.

You may not qualify if:

• i. Patients who do not meet the criteria for the use of speaking valve (i.e. unconscious and/or comatose patients, patients who require 24-hour inflated tracheostomy tube cuff due to inadequate ventilation, foam-filled tracheostomy tube, severe airway obstruction, unmanageable thick secretions, severe risk for aspiration, severely reduced lung elasticity, and not intended for use with endotracheal tubes).
• ii. Patients with an acute illness and is not at baseline status. iii. Have any kind of respiratory distress.

Sponsors & Collaborators

• St Mary's Hospital for Children: lead

Related Publications (5)

• Barraza GY, Fernandez C, Halaby C, Ambrosio S, Simpser EF, Pirzada MB, Islam S. The safety of tracheostomy speaking valve use during sleep in children: a pilot study. Am J Otolaryngol. 2014 Sep-Oct;35(5):636-40. doi: 10.1016/j.amjoto.2014.04.011. Epub 2014 May 4.

  PMID: 24888795 RESULT

• Brigger MT, Hartnick CJ. Drilling speaking valves: a modification to improve vocalization in tracheostomy dependent children. Laryngoscope. 2009 Jan;119(1):176-9. doi: 10.1002/lary.20077.

  PMID: 19117281 RESULT

• Buckland A, Jackson L, Ilich T, Lipscombe J, Jones G, Vijayasekaran S. Drilling speaking valves to promote phonation in tracheostomy-dependent children. Laryngoscope. 2012 Oct;122(10):2316-22. doi: 10.1002/lary.23436. Epub 2012 Jul 9.

  PMID: 22777746 RESULT

• Hopkins C, Whetstone S, Foster T, Blaney S, Morrison G. The impact of paediatric tracheostomy on both patient and parent. Int J Pediatr Otorhinolaryngol. 2009 Jan;73(1):15-20. doi: 10.1016/j.ijporl.2008.09.010. Epub 2008 Nov 18.

  PMID: 19019462 RESULT

• Johnson DC, Campbell SL, Rabkin JD. Tracheostomy tube manometry: evaluation of speaking valves, capping and need for downsizing. Clin Respir J. 2009 Jan;3(1):8-14. doi: 10.1111/j.1752-699X.2008.00100.x.

  PMID: 20298366 RESULT

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Melodi Pirzada, MD

  St Mary's Healthcare System for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 17, 2016
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: November 21, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share