TracheostomyPhase 2/3NCT00978783
Speech Effects of a Speaking Valve Versus External Positive End-expiratory Pressure (PEEP) in Tracheostomized Ventilator-Dependent Neuromuscular Patients
A Phase 2/3 study testing Passy Muir Valve and Positive end expiratory pressure in people with Tracheostomy and Mechanical Ventilation, run by University of Versailles at 1 site in France.
Trial summary
Background: Many patients with respiratory failure related to neuromuscular disease receive chronic invasive ventilation through a tracheostomy. Improving quality of life, of which speech is an important component, is a major goal in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheostomy, Mechanical Ventilation
- What is being tested?
- Passy Muir Valve and Positive end expiratory pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Apr 2009
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neuromuscular patients
- Patients received mechanical ventilation via a cuffless tracheostomy
Who cannot join
- Acute respiratory failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Speech Effects of a Speaking Valve Versus External PEEP in Tracheostomized Ventilator-Dependent Neuromuscular Patients
Background:
Many patients with respiratory failure related to neuromuscular disease receive chronic invasive ventilation through a tracheostomy. Improving quality of life, of which speech is an important component, is a major goal in these patients. The investigators compared the effects on breathing and speech of low-level positive end-expiratory pressure (PEEP, 5 cm H2O) and of a Passy-Muir speaking valve (PMV) during assist-control ventilation.
Read more
Methods:
Flow will be measured using a pneumotachograph. Microphone speech recordings were subjected to both quantitative measurements and qualitative assessments; these last consisted of a perceptual score and an intelligibility score determined by two speech therapists using a French adaptation of the Frenchay Dysarthria Assessment.
Read the detailed description
METHODS
Patients 10 ventilator-dependent patients with neuromuscular disease. All patients will receive mechanical ventilation via a cuffless tracheostomy. The study protocol was approved by our institutional review board, and written informed consent will be obtained from all patients before study inclusion.
Experimental setup Ventilator-delivered flow will be measured using a pneumotachograph (Fleisch #2, Lausanne, Switzerland) and tracheal pressure at the proximal end of the tracheostomy tube using a differential pressure transducer (Validyne MP 45±100 cm H2O, Northridge, CA, USA). To assess patient gas exchange, oxygen saturation (SpO2) will be estimated using pulse oximetry (Ohmeda Biox, BOC Healthcare, Boulder, CO, USA).
Acoustic speech signals will be recorded using three methods. The signals recorded from a microphone (DM202, MDE, Pierron, Sarreguemines, France) positioned 20 cm from the patient's lips were routed to a microcomputer with an AD converter (MP150® and Acqknowledge®, Biopac system, Goleta, CA, USA) that synchronized respiratory data (ventilator flow and tracheal pressure) and acoustic data. The AD converter will digitize respiratory signals at 128 Hz and speech signals at 20 000 Hz. The acoustic signal will be also routed to the Dragon NaturallySpeaking 10® speech recognition system (Nuance; Burlington, MA, USA) with its specific microphone and a laptop computer containing its speech recognition software. Finally, the acoustic signal will be recorded on a digital recorder (DS55, Olympus®, Herodphot, Manage, France) with a signal bandwidth between 50 and 19 000 Hz to allow assessment of fundamental frequency and subsequent qualitative analysis by speech therapists.
Experimental protocol All patients will be receiving ACV, the ventilation mode used in all tracheostomized patients followed at our neuromuscular unit. VI, TI, backup rate, and inspiratory trigger sensitivity will be kept unchanged. Before testing, patients will be familiarized with the use of 5 cm H2O PEEP and of the PMV. These two conditions will be tested in random order. With each condition, the patient first will use the Dragon NaturallySpeaking 10® voice-training menu, which involves reading a text passage for 10 minutes to enable software training. Then, the patient will continuously utter the [a] sound for as long as possible, read a list of words, utter the [a] sound in a glissando from high pitch to low pitch then from low pitch to high pitch, and read a standard text passage.
Data analysis RR, TI, VI, and the volume expired through the tracheostomy tube (VE) will be measured based on the computerized flow signal. The difference between VI and VE will be used as an approximation of the volume expired through the upper airway. Ventilator triggering by the patient will be considered significant when RR exceeded the backup rate by at least 3 cycles/min.
Speech will be evaluated by measuring the mean time spent speaking during the respiratory cycle, time needed to read the text passage, ability of Dragon NaturallySpeaking 10® to accurately recognize the spoken words, and perceptual analyses by two speech therapists blinded to speech condition. The numbers of grammatical and phonological errors made by Dragon NaturallySpeaking 10® during the standard text reading will be compared between PEEP and PMV. The two speech therapists will assess the recordings presented in pairs, with PEEP vs. PMV in random order. The intelligibility scale used will be a French adaptation of the Frenchay Dysarthria Assessment (0 to 8 scale). In addition, the speech therapists will determine a perceptual score on a 0-128 scale developed by the French authors who adapted the Frenchay Dysarthria Assessment.
At the end of each trial, the patients will evaluate subjective respiratory comfort and subjective speech comfort on 10-cm horizontal visual analog scales (VASs).
Statistical analysis All results will be expressed as means±standard deviation (SD). Differences between the two conditions will be assessed using a paired t test. P values <0.05 will be considered statistically significant.
- Conditions
- Tracheostomy, Mechanical Ventilation
- Being tested
- Passy Muir Valve, Positive end expiratory pressure
- Keywords
- Phonation, Tracheostomy, phonation valve, positive end expiratory pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passy Muir ValveDevice
Also called phonation valve
The Passy Muir Valve was fixed on the tracheostomy tube
Positive end expiratory pressureDevice
Also called PEEP
5 cm H2O PEEP was adjusted
| Study group | Role | What they receive |
|---|---|---|
| speaking valve | Active comparator | Not described Receives: Device: Passy Muir Valve |
| Positive end expiratory pressure | Active comparator | Not described Receives: Device: Positive end expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
text reading duration
Measured: 1 hour
Secondary outcomes (5)
respiratory comfort
Measured: 1 hour
speech comfort
Measured: 2 hours
Dragon NaturallySpeaking 10® system ability to recognise the speech
Measured: 30 minutes
Sustained [a] duration
Measured: 15 minutes
perceptual score and intelligibility score determined by 2 blinded speech therapists
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheostomyStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Versailles
- Sponsor type
- University, hospital or other
- Investigators
- Djillali Annane, MD, PhD, Study chair, CIC-IT, R. Poincaré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978783
- Sponsor's protocol ID
- PMV vs PEEP
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 17 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Effects of a Speaking Valve Versus External PEEP in Tracheostomized Ventilator-Dependent Neuromuscular Patients
- ClinicalTrials.gov ID
- NCT00978783
- Acronym / sponsor ID
- PMV vs PEEP
- Conditions
- Tracheostomy, Mechanical Ventilation
- Keywords
- Phonation, Tracheostomy, phonation valve, positive end expiratory pressure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of VersaillesUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 17 Sep 2009 (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.
Background:
Many patients with respiratory failure related to neuromuscular disease receive chronic invasive ventilation through a tracheostomy. Improving quality of life, of which speech is an important component, is a major goal in these patients. The investigators compared the effects on breathing and speech of low-level positive end-expiratory pressure (PEEP, 5 cm H2O) and of a Passy-Muir speaking valve (PMV) during assist-control ventilation.
Methods:
Flow will be measured using a pneumotachograph. Microphone speech recordings were subjected to both quantitative measurements and qualitative assessments; these last consisted of a perceptual score and an intelligibility score determined by two speech therapists using a French adaptation of the Frenchay Dysarthria Assessment.
Detailed description
METHODS
Patients 10 ventilator-dependent patients with neuromuscular disease. All patients will receive mechanical ventilation via a cuffless tracheostomy. The study protocol was approved by our institutional review board, and written informed consent will be obtained from all patients before study inclusion.
Experimental setup Ventilator-delivered flow will be measured using a pneumotachograph (Fleisch #2, Lausanne, Switzerland) and tracheal pressure at the proximal end of the tracheostomy tube using a differential pressure transducer (Validyne MP 45±100 cm H2O, Northridge, CA, USA). To assess patient gas exchange, oxygen saturation (SpO2) will be estimated using pulse oximetry (Ohmeda Biox, BOC Healthcare, Boulder, CO, USA).
Acoustic speech signals will be recorded using three methods. The signals recorded from a microphone (DM202, MDE, Pierron, Sarreguemines, France) positioned 20 cm from the patient's lips were routed to a microcomputer with an AD converter (MP150® and Acqknowledge®, Biopac system, Goleta, CA, USA) that synchronized respiratory data (ventilator flow and tracheal pressure) and acoustic data. The AD converter will digitize respiratory signals at 128 Hz and speech signals at 20 000 Hz. The acoustic signal will be also routed to the Dragon NaturallySpeaking 10® speech recognition system (Nuance; Burlington, MA, USA) with its specific microphone and a laptop computer containing its speech recognition software. Finally, the acoustic signal will be recorded on a digital recorder (DS55, Olympus®, Herodphot, Manage, France) with a signal bandwidth between 50 and 19 000 Hz to allow assessment of fundamental frequency and subsequent qualitative analysis by speech therapists.
Experimental protocol All patients will be receiving ACV, the ventilation mode used in all tracheostomized patients followed at our neuromuscular unit. VI, TI, backup rate, and inspiratory trigger sensitivity will be kept unchanged. Before testing, patients will be familiarized with the use of 5 cm H2O PEEP and of the PMV. These two conditions will be tested in random order. With each condition, the patient first will use the Dragon NaturallySpeaking 10® voice-training menu, which involves reading a text passage for 10 minutes to enable software training. Then, the patient will continuously utter the [a] sound for as long as possible, read a list of words, utter the [a] sound in a glissando from high pitch to low pitch then from low pitch to high pitch, and read a standard text passage.
Data analysis RR, TI, VI, and the volume expired through the tracheostomy tube (VE) will be measured based on the computerized flow signal. The difference between VI and VE will be used as an approximation of the volume expired through the upper airway. Ventilator triggering by the patient will be considered significant when RR exceeded the backup rate by at least 3 cycles/min.
Speech will be evaluated by measuring the mean time spent speaking during the respiratory cycle, time needed to read the text passage, ability of Dragon NaturallySpeaking 10® to accurately recognize the spoken words, and perceptual analyses by two speech therapists blinded to speech condition. The numbers of grammatical and phonological errors made by Dragon NaturallySpeaking 10® during the standard text reading will be compared between PEEP and PMV. The two speech therapists will assess the recordings presented in pairs, with PEEP vs. PMV in random order. The intelligibility scale used will be a French adaptation of the Frenchay Dysarthria Assessment (0 to 8 scale). In addition, the speech therapists will determine a perceptual score on a 0-128 scale developed by the French authors who adapted the Frenchay Dysarthria Assessment.
At the end of each trial, the patients will evaluate subjective respiratory comfort and subjective speech comfort on 10-cm horizontal visual analog scales (VASs).
Statistical analysis All results will be expressed as means±standard deviation (SD). Differences between the two conditions will be assessed using a paired t test. P values <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| speaking valve | Active comparator | Device: Passy Muir Valve |
| Positive end expiratory pressure | Active comparator | Device: Positive end expiratory pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Neuromuscular patients
- Patients received mechanical ventilation via a cuffless tracheostomy
Key exclusion criteria (1 listed)
- Acute respiratory failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passy Muir ValveAlso: phonation valveThe Passy Muir Valve was fixed on the tracheostomy tube | Device | speaking valve |
| Positive end expiratory pressureAlso: PEEP5 cm H2O PEEP was adjusted | Device | Positive end expiratory pressure |
Primary outcome
text reading duration
Time frame: 1 hour
5 secondary outcomes
respiratory comfort
Time frame: 1 hour
speech comfort
Time frame: 2 hours
Dragon NaturallySpeaking 10® system ability to recognise the speech
Time frame: 30 minutes
Sustained [a] duration
Time frame: 15 minutes
perceptual score and intelligibility score determined by 2 blinded speech therapists
Time frame: 2 hours
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 17 Sep 2009.
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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.
Djillali Annane, MD, PhD study chair
CIC-IT, R. Poincaré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Passy Muir Valve and Positive end expiratory pressure in people with Tracheostomy and Mechanical Ventilation, run by University of Versailles at 1 site in France.
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 2 inclusion and 1 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 17 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
text reading duration (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2009.