Chronic Respiratory FailureOptiPEPNCT01479959
Impact of Patient Controlled Positive End-expiratory Pressure on Speech in Tracheostomized Ventilated Patients
A study testing Eole 3 ventilator - Resmed in people with Chronic Respiratory Failure, run by University of Versailles at 1 site in France.
Trial summary
Adequate communication is a major part of the quality of life of tracheostomized ventilator dependent patients. Maintaining speech is therefore major goal in the management of these patients. The use of a positive end-expiratory pressure (PEEP) during ventilation has allowed the improvement of speech. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure
- What is being tested?
- Eole 3 ventilator - Resmed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jul 2011
- Phase
- Interventional
- 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
- Adult patient
- Stable state upon inclusion
- Neuromuscular patients, tracheostomized and on long term ventilation with a cuffless tube
- Assist control volumetric ventilation mode
- Signed consent form
Who cannot join
- Pregnancy
- Patients unable to read
- Acute respiratory failure
- Contra-indication of PEEP use
- Lack of social security coverage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of Optimal PEEP Level Under Patient Control in Tracheostomized Ventilated Patients
Adequate communication is a major part of the quality of life of tracheostomized ventilator dependent patients. Maintaining speech is therefore major goal in the management of these patients.
The use of a positive end-expiratory pressure (PEEP) during ventilation has allowed the improvement of speech. The best level for speech may vary from one patient to the other The purpose of this study is to determine individually the most efficient PEEP level in terms of speech while obtaining the most secure condition and the best possible respiratory tolerance. In order to improve the latter, the investigators will use a device which allows the patients to control the activation of PEEP so that they can use it only when needed (i.e. when they wish to speak). The investigators will compare the effect of different PEEP level to try to determine the best compromise to improve speech in tracheostomized ventilator-dependent patients.
Read the detailed description
Context :
Allowing a functional communication is a major issue in order to preserve quality of life in tracheostomized ventilator-dependent patients.
We showed in a previous study that the use of a positive end-expiratory pressure (PEEP) in neuromuscular tracheostomized ventilator-dependent patients improved speech as it allows the patient to expire (at least partly) through the upper airways therefore to speak during expiration. The use of PEEP has been compared to the use of a phonation valve placed on the ventilator circuit which allows a complete expiration through the upper airways and therefore speech. Both techniques seem similar in terms of efficiency on speech; PEEP, however, is better tolerated and seems to be more secure (the system remains open during expiration decreasing the risk of high pressure, it does not require any handling of the ventilator circuit).
Optimal PEEP level allowing the patient to expire the total expiratory volume through the upper airways PEEPeff may vary from one patient to the other. We seek to determine individual PEEPeff and to compare it to 50% of its value (PEEPef50). Indeed, while PEEPeff may constitute the best level for expiratory speech as it mimics the mechanisms of a phonation valve without some of its fallbacks, by preventing expiration through the expiratory circuit of the ventilator, it also may lengthen expiration, delaying inspiration which allows speech, and facilitate hyperinflation leading to respiratory discomfort as we have previously observed with some patients using a phonation valve. Optimal PEEP level would be the best compromise between best possible phonation and best possible respiratory comfort and therefore could be lower than PEEPeff.
In order to improve respiratory comfort with higher PEEP level, we developed a prototype ventilator in which PEEP is activated by a switch under the control of patients who may activate it only when needed (during speech period).
Objective :
The main objective of the study is to optimize PEEP use both by determining individually its most appropriate level and by evaluation its use overtime to allow the best possible speech with the best respiratory comfort and the most secure condition for tracheostomized ventilated patients. Different PEEP levels will be evaluated and PEEP activation will be controlled by the patients.
Methods:
Open randomized monocentric cross-over study (the patients are their own control).
Optimal PEEP level (PEEPeff), defined as PEEP-level allowing complete expiration through the upper airways, will be determined for each patient. Speech and respiratory parameters were studied without PEEP, with PEEPeff and an intermediate PEEP-level(PEEP50). Flow and airway pressure will be measure and upper airways resistance will be calculated. Microphone speech recordings were subjected to both quantitative measurements and qualitative assessments of speech.
For each PEEP level the following protocol will be conducted: 5 minutes of quiet breathing with PEEP, 10 minutes spontaneous conversation, then speech trial(maximal sustained sound, glissando, text reading).
Subjective evaluation of speech and respiratory comfort(by the patient) and objective evaluation of speech improvement according to PEEP level (reading duration, phonation duration, voice quality, assessments of speech including an intelligibility score, a perceptual score and an evaluation of prosody analyzed by two experimented speech therapists blinded to PEEP level). Evaluation of the PEEP control button use by the patient.
Inclusion criteria:
Neuromuscular adult patients, tracheotomized and on long-term ventilation with a cuffless tube, on assist-control volumetric ventilation, in stable state at the time of the study.
Number of patients, center:
Considering it is a pilot study, 14 subjects will be included for the study. The subjects will be recruited in the home ventilation unit of the intensive care department of the R. Poincare teaching hospital (Garches, France) during their usual follow-up for their chronic respiratory failure.
Duration of study: 12 months. Duration of participation for each patient will be 1h30.
- Conditions
- Chronic Respiratory Failure
- Being tested
- Eole 3 ventilator - Resmed
- Keywords
- Tracheostomy, positive end expiratory pressure, speech, respiratory failure, ventilation, neuromuscular disorders
- Medical subject headings
- Speech, Respiratory Insufficiency, Respiratory Aspiration, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eole 3 ventilator - ResmedDevice
Also called Goodnight 420E, Tyco Healthcare, Puritan Bennett
positive end expiratory pressure is added to the ventilation mode and it is activated by a switch under patient's control
| Study group | Role | What they receive |
|---|---|---|
| No PEEP level | Active comparator | protocol conducted while no PEEP is applied Receives: Device: Eole 3 ventilator - Resmed |
| effective PEEP level (PEEPeff) | Active comparator | PEEP level allowing the entire expiratory volume to go through the upper airways during quiet breathing Receives: Device: Eole 3 ventilator - Resmed |
| intermediate PEEP level (PEEP50) | Active comparator | 50% of PEEPeff Receives: Device: Eole 3 ventilator - Resmed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of PEEP level on speech
Measurement of the duration of a text passage reading, the maximal phonation time throughout the repsiratory cycle.
Measured: 20 minutes
Secondary outcomes (4)
Effect of PEEP level on voice quality
Subjective evaluation by the patients with a visual analogic scale. Objective evaluation by two speech therapists (blinded to speech condition)assessing intelligibility, perceptual quality and prosody
Measured: 20 minutes
Respiratory Comfort evaluated with a visual analogic scale by patients
Measured: 20 minutes
Respiratory tolerance
Evaluation of respiratory tolerance through measurements of oxygen saturation , heart rate and respiratory rate
Measured: 20 minute
Use of PEEP control switch
number of use of the PEEP control switch during the text passage reading
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory FailureStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Versailles
- Sponsor type
- University, hospital or other
- Collaborators
- Adep Assistance
- Responsible party
- Principal investigator, PRIGENT, University of Versailles
- Investigators
- Helene PRIGENT, MD, Principal investigator, Hôpital Raymond Poincaré - APHPFrederic LOFASO, MD-PhD, Study director, University of Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01479959
- Sponsor's protocol ID
- Optipep -10-007
- Acronym
- OptiPEP
- Status last verified
- Nov 2011
- First submitted
- 17 Nov 2011
- Last updated
- 28 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Prigent H, Samuel C, Louis B, Abinun MF, Zerah-Lancner F, Lejaille M, Raphael JC, Lofaso F. Comparative effects of two ventilatory modes on speech in tracheostomized patients with neuromuscular disease. Am J Respir Crit Care Med. 2003 Jan 15;167(2):114-9. doi: 10.1164/rccm.200201-026OC. Epub 2002 Oct 4.
PubMed 12406841Prigent H, Garguilo M, Pascal S, Pouplin S, Bouteille J, Lejaille M, Orlikowski D, Lofaso F. Speech effects of a speaking valve versus external PEEP in tracheostomized ventilator-dependent neuromuscular patients. Intensive Care Med. 2010 Oct;36(10):1681-1687. doi: 10.1007/s00134-010-1935-0. Epub 2010 Jun 10.
PubMed 20535605Pellegrini N, Pelletier A, Orlikowski D, Lolierou C, Ruquet M, Raphael JC, Lofaso F. Hand versus mouth for call-bell activation by DMD and Becker patients. Neuromuscul Disord. 2007 Jul;17(7):532-6. doi: 10.1016/j.nmd.2007.03.016. Epub 2007 May 29.
PubMed 17533130Bach JR, Alba AS. Tracheostomy ventilation. A study of efficacy with deflated cuffs and cuffless tubes. Chest. 1990 Mar;97(3):679-83. doi: 10.1378/chest.97.3.679.
PubMed 2407453Hoit JD, Banzett RB, Lohmeier HL, Hixon TJ, Brown R. Clinical ventilator adjustments that improve speech. Chest. 2003 Oct;124(4):1512-21. doi: 10.1378/chest.124.4.1512.
PubMed 14555587Hoit JD, Shea SA, Banzett RB. Speech production during mechanical ventilation in tracheostomized individuals. J Speech Hear Res. 1994 Feb;37(1):53-63. doi: 10.1044/jshr.3701.53.
PubMed 8170131Garguilo M, Leroux K, Lejaille M, Pascal S, Orlikowski D, Lofaso F, Prigent H. Patient-controlled positive end-expiratory pressure with neuromuscular disease: effect on speech in patients with tracheostomy and mechanical ventilation support. Chest. 2013 May;143(5):1243-1251. doi: 10.1378/chest.12-0574.
PubMed 23715608
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Optimal PEEP Level Under Patient Control in Tracheostomized Ventilated Patients
- ClinicalTrials.gov ID
- NCT01479959
- Acronym / sponsor ID
- OptiPEP / Optipep -10-007
- Conditions
- Chronic Respiratory Failure
- Keywords
- Tracheostomy, positive end expiratory pressure, speech, respiratory failure, ventilation, neuromuscular disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of VersaillesUniversity, hospital or other
- Collaborators
- Adep Assistance
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 28 Nov 2011 (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.
Adequate communication is a major part of the quality of life of tracheostomized ventilator dependent patients. Maintaining speech is therefore major goal in the management of these patients.
The use of a positive end-expiratory pressure (PEEP) during ventilation has allowed the improvement of speech. The best level for speech may vary from one patient to the other The purpose of this study is to determine individually the most efficient PEEP level in terms of speech while obtaining the most secure condition and the best possible respiratory tolerance. In order to improve the latter, the investigators will use a device which allows the patients to control the activation of PEEP so that they can use it only when needed (i.e. when they wish to speak). The investigators will compare the effect of different PEEP level to try to determine the best compromise to improve speech in tracheostomized ventilator-dependent patients.
Detailed description
Context :
Allowing a functional communication is a major issue in order to preserve quality of life in tracheostomized ventilator-dependent patients.
We showed in a previous study that the use of a positive end-expiratory pressure (PEEP) in neuromuscular tracheostomized ventilator-dependent patients improved speech as it allows the patient to expire (at least partly) through the upper airways therefore to speak during expiration. The use of PEEP has been compared to the use of a phonation valve placed on the ventilator circuit which allows a complete expiration through the upper airways and therefore speech. Both techniques seem similar in terms of efficiency on speech; PEEP, however, is better tolerated and seems to be more secure (the system remains open during expiration decreasing the risk of high pressure, it does not require any handling of the ventilator circuit).
Optimal PEEP level allowing the patient to expire the total expiratory volume through the upper airways PEEPeff may vary from one patient to the other. We seek to determine individual PEEPeff and to compare it to 50% of its value (PEEPef50). Indeed, while PEEPeff may constitute the best level for expiratory speech as it mimics the mechanisms of a phonation valve without some of its fallbacks, by preventing expiration through the expiratory circuit of the ventilator, it also may lengthen expiration, delaying inspiration which allows speech, and facilitate hyperinflation leading to respiratory discomfort as we have previously observed with some patients using a phonation valve. Optimal PEEP level would be the best compromise between best possible phonation and best possible respiratory comfort and therefore could be lower than PEEPeff.
In order to improve respiratory comfort with higher PEEP level, we developed a prototype ventilator in which PEEP is activated by a switch under the control of patients who may activate it only when needed (during speech period).
Objective :
The main objective of the study is to optimize PEEP use both by determining individually its most appropriate level and by evaluation its use overtime to allow the best possible speech with the best respiratory comfort and the most secure condition for tracheostomized ventilated patients. Different PEEP levels will be evaluated and PEEP activation will be controlled by the patients.
Methods:
Open randomized monocentric cross-over study (the patients are their own control).
Optimal PEEP level (PEEPeff), defined as PEEP-level allowing complete expiration through the upper airways, will be determined for each patient. Speech and respiratory parameters were studied without PEEP, with PEEPeff and an intermediate PEEP-level(PEEP50). Flow and airway pressure will be measure and upper airways resistance will be calculated. Microphone speech recordings were subjected to both quantitative measurements and qualitative assessments of speech.
For each PEEP level the following protocol will be conducted: 5 minutes of quiet breathing with PEEP, 10 minutes spontaneous conversation, then speech trial(maximal sustained sound, glissando, text reading).
Subjective evaluation of speech and respiratory comfort(by the patient) and objective evaluation of speech improvement according to PEEP level (reading duration, phonation duration, voice quality, assessments of speech including an intelligibility score, a perceptual score and an evaluation of prosody analyzed by two experimented speech therapists blinded to PEEP level). Evaluation of the PEEP control button use by the patient.
Inclusion criteria:
Neuromuscular adult patients, tracheotomized and on long-term ventilation with a cuffless tube, on assist-control volumetric ventilation, in stable state at the time of the study.
Number of patients, center:
Considering it is a pilot study, 14 subjects will be included for the study. The subjects will be recruited in the home ventilation unit of the intensive care department of the R. Poincare teaching hospital (Garches, France) during their usual follow-up for their chronic respiratory failure.
Duration of study: 12 months. Duration of participation for each patient will be 1h30.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No PEEP level | Active comparator | Device: Eole 3 ventilator - Resmedprotocol conducted while no PEEP is applied |
| effective PEEP level (PEEPeff) | Active comparator | Device: Eole 3 ventilator - ResmedPEEP level allowing the entire expiratory volume to go through the upper airways during quiet breathing |
| intermediate PEEP level (PEEP50) | Active comparator | Device: Eole 3 ventilator - Resmed50% of PEEPeff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient
- Stable state upon inclusion
- Neuromuscular patients, tracheostomized and on long term ventilation with a cuffless tube
- Assist control volumetric ventilation mode
- Signed consent form
Key exclusion criteria (5 listed)
- Pregnancy
- Patients unable to read
- Acute respiratory failure
- Contra-indication of PEEP use
- Lack of social security coverage
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 |
|---|---|---|
| Eole 3 ventilator - ResmedAlso: Goodnight 420E, Tyco Healthcare, Puritan Bennettpositive end expiratory pressure is added to the ventilation mode and it is activated by a switch under patient's control | Device | No PEEP level, effective PEEP level (PEEPeff), intermediate PEEP level (PEEP50) |
Primary outcome
Efficiency of PEEP level on speech
Time frame: 20 minutes
Measurement of the duration of a text passage reading, the maximal phonation time throughout the repsiratory cycle.
4 secondary outcomes
Effect of PEEP level on voice quality
Time frame: 20 minutes
Respiratory Comfort evaluated with a visual analogic scale by patients
Time frame: 20 minutes
Respiratory tolerance
Time frame: 20 minute
Use of PEEP control switch
Time frame: 20 minutes
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 28 Nov 2011.
- Background: PubMed 12406841Prigent H, Samuel C, Louis B, Abinun MF, Zerah-Lancner F, Lejaille M, Raphael JC, Lofaso F. Comparative effects of two ventilatory modes on speech in tracheostomized patients with neuromuscular disease. Am J Respir Crit Care Med. 2003 Jan 15;167(2):114-9. doi: 10.1164/rccm.200201-026OC. Epub 2002 Oct 4.
- Background: PubMed 20535605Prigent H, Garguilo M, Pascal S, Pouplin S, Bouteille J, Lejaille M, Orlikowski D, Lofaso F. Speech effects of a speaking valve versus external PEEP in tracheostomized ventilator-dependent neuromuscular patients. Intensive Care Med. 2010 Oct;36(10):1681-1687. doi: 10.1007/s00134-010-1935-0. Epub 2010 Jun 10.
- Background: PubMed 17533130Pellegrini N, Pelletier A, Orlikowski D, Lolierou C, Ruquet M, Raphael JC, Lofaso F. Hand versus mouth for call-bell activation by DMD and Becker patients. Neuromuscul Disord. 2007 Jul;17(7):532-6. doi: 10.1016/j.nmd.2007.03.016. Epub 2007 May 29.
- Background: PubMed 2407453Bach JR, Alba AS. Tracheostomy ventilation. A study of efficacy with deflated cuffs and cuffless tubes. Chest. 1990 Mar;97(3):679-83. doi: 10.1378/chest.97.3.679.
- Background: PubMed 14555587Hoit JD, Banzett RB, Lohmeier HL, Hixon TJ, Brown R. Clinical ventilator adjustments that improve speech. Chest. 2003 Oct;124(4):1512-21. doi: 10.1378/chest.124.4.1512.
- Background: PubMed 8170131Hoit JD, Shea SA, Banzett RB. Speech production during mechanical ventilation in tracheostomized individuals. J Speech Hear Res. 1994 Feb;37(1):53-63. doi: 10.1044/jshr.3701.53.
- Derived from this study: PubMed 23715608Garguilo M, Leroux K, Lejaille M, Pascal S, Orlikowski D, Lofaso F, Prigent H. Patient-controlled positive end-expiratory pressure with neuromuscular disease: effect on speech in patients with tracheostomy and mechanical ventilation support. Chest. 2013 May;143(5):1243-1251. doi: 10.1378/chest.12-0574.
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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.
Helene PRIGENT, MD principal investigator
Hôpital Raymond Poincaré - APHP
Frederic LOFASO, MD-PhD study director
University of Versailles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eole 3 ventilator - Resmed in people with Chronic Respiratory Failure, 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 5 inclusion and 5 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 28 Nov 2011. 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.
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?
Efficiency of PEEP level on speech (time frame: 20 minutes). 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 NCT01479959, which also lists 7 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 28 Nov 2011.