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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Intensive care Ward of R. Poincaré Hospital

    Garches, 92380

Other trials in France

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.

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 groups in NCT00978783
Study groupRoleWhat they receive
speaking valveActive comparatorNot described
Receives: Device: Passy Muir Valve
Positive end expiratory pressureActive comparatorNot described
Receives: Device: Positive end expiratory pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. text reading duration

    Measured: 1 hour

Secondary outcomes (5)
  1. respiratory comfort

    Measured: 1 hour

  2. speech comfort

    Measured: 2 hours

  3. Dragon NaturallySpeaking 10® system ability to recognise the speech

    Measured: 30 minutes

  4. Sustained [a] duration

    Measured: 15 minutes

  5. 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.

  1. First posted17 Sep 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

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)
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

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.

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