Chronic Lung Disease of PrematurityNCT02935140
Safe Use of Speaking Valve in Children During Sleep Using Trans-tracheal Pressure Measurement
An observational study of Chronic Lung Disease of Prematurity and Chronic Respiratory Failure, run by St Mary's Hospital for Children.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Chronic Lung Disease of Prematurity, Chronic Respiratory Failure
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
- Patients with an acute illness and is not at baseline status. iii. Have any kind of respiratory distress.
About this study
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.
Read the 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:
- 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.
- Medical subject headings
- Bronchopulmonary Dysplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans-tracheal Pressure Measurement
trans-tracheal manometry measurement is similar while on the Passy-Muir speaking valve when patients are awake and asleep
Measured: one day
Secondary outcomes (2)
Recording of symptoms
- 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
Measured: one day
vital signs
- 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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startDec 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Lung Disease of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Mary's Hospital for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melodi Pirzada, MD, Principal investigator, St Mary's Healthcare System for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935140
- Sponsor's protocol ID
- 2015-09
- Status last verified
- Nov 2016
- First submitted
- 13 Oct 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 24888795Brigger 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.
PubMed 19117281Buckland 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.
PubMed 22777746Hopkins 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.
PubMed 19019462Johnson 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.
PubMed 20298366
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Use of Speaking Valve in Children During Sleep Using Trans-tracheal Pressure Measurement
- ClinicalTrials.gov ID
- NCT02935140
- Acronym / sponsor ID
- 2015-09
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- St Mary's Hospital for ChildrenUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
- Patients with an acute illness and is not at baseline status. iii. Have any kind of respiratory distress.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trans-tracheal Pressure Measurement
Time frame: one day
trans-tracheal manometry measurement is similar while on the Passy-Muir speaking valve when patients are awake and asleep
2 secondary outcomes
Recording of symptoms
Time frame: one day
vital signs
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Results publication: PubMed 24888795Barraza 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.
- Results publication: PubMed 19117281Brigger 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.
- Results publication: PubMed 22777746Buckland 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.
- Results publication: PubMed 19019462Hopkins 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.
- Results publication: PubMed 20298366Johnson 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.
- Individual participant dataSharing planned: Yes
Related trials for Chronic Lung Disease of Prematurity
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melodi Pirzada, MD principal investigator
St Mary's Healthcare System for Children
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lung Disease of Prematurity and Chronic Respiratory Failure, run by St Mary's Hospital for Children.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trans-tracheal Pressure Measurement (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02935140, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.