Respiratory FailureTELERESPNCT01807663
Validation of a Dynamic Evaluation Tool in Respiratory Failure
A study testing healthy volonteers and Free breath monitoring in people with Respiratory Failure, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
Determing optimal time of ventilator disconnection is a challenge for both acute and chronic neuromuscular disease. In one case it is helpful for weanning from ventilator and in the other to optimize daytime ventilation in the most severe patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- healthy volonteers and Free breath monitoring
- 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
- Nov 2012to Jun 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volonteers Man or woman of more than 18 years Realization of a preliminary medical examination Patient having signed an informed and written consent Major healthy subjects, presenting no chronic pathology or not chronic patients
- Chronic patients Man or woman of more than 18 years Affected by neuromuscular pathology Realization of a preliminary medical examination Patient in the stable state at the time of the study for at least 1 month Ventilated in a not invasive or invasive way in diurnal and night-period. Respiratory autonomy > 1:00 am Patient having signed an informed and written consent
- Acute Patients Man or woman of more than 18 years Affected by syndrome of Guillain blocked in aigue phase having required the invasive ventilation or affected by myasthenia generalized with myasthénique crisis having required the invasive ventilation.
- Realization of a preliminary medical examination Patient in phase of neurological recovery Vital Capacity > 15 ml / kg Respiratory Autonomy > 1:00 am Patient having signed a lit(enlightened) and written consent
Who cannot join
- Healthy volonteers subject refusing to participate in the study subject under guardianship or guardianship Pregnant or breast-feeding Woman
- Chronic patients Patient refusing to participate in the study Patient under guardianship or guardianship Pregnant or breast-feeding Woman Patients ventilated only at night Clinically significant bronchial Dimensions(Congestion) Required by oxygen therapy
- Acute patients Patient refusing to participate in the study Patient or subject under guardianship or guardianship Pregnant or breast-feeding Woman Clinically significant bronchial Dimensions(Congestion) Required by oxygen therapy FIO2 > 40 % PEP > 5 cms H2O State of shock
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Dynamic Evaluation Tool in Respiratory Failure by Ambulatory Inductance Plethysmography
Determing optimal time of ventilator disconnection is a challenge for both acute and chronic neuromuscular disease. In one case it is helpful for weanning from ventilator and in the other to optimize daytime ventilation in the most severe patients. The investigators propose to validate a new non invasive tool for monitoring respiratroy parameters in neuromuscular patients in both acute and chronic conditions.
Read the detailed description
Context:
Mechanical ventilation transformed the prognosis of neuromuscular diseases whether for acute or chronic diseases. The available tools to estimate the severity of respiratory insufficiency and indicate or follow the efficiency of mechanical ventilation are based on blood gazes explorations, tests respiratory function and sleep evaluation.
These tools give either limited information, or are with difficulty applicable to patients heavily handicapped except during hospitalization.
In patients under mechanical ventilation, it is sometimes difficult to know the daily optimal time of ventilation. The respiratory events are not generally recognized and are unspecific (headaches, drowsiness, dyspnoea, etc.) or are identified by blood gazes abnormalities (hypercapnia. In acute setting, treble is going to raise the problem of the weaning of the mechanical ventilation and the optimal moment of the extubation without risking a reintubation.
These problems are identical and concern the evaluation of the degree of ventilatory autonomy for home care. The development of methods estimating this autonomy is thus fundamental.
Objectives: the objective of this project is to validate a non-invasive system for measure and acquisition of respiratory parameters, incorporating a transmission system working by a "wireless" technology allowing the remote monitoring of these patients.
The secondary objectives are to determine the parameters of success of weaning by using the device in neuromuscular patients intubated for respiratory failure in acute setting and to determine the optimal time of free breathing possibilities in patients ventilated in a chronic way at home.
Methods:
After validation of the device on 10 healthy subjects, continuous acquisition of the ventilatory data by means of the Teleresp system compared with measure of the transcutaneous PCO2, of SaO2 and arterial gazometry at the end of free breath trial in 40 acute and chronic neuromuscular patients.
Selection criteria:
Healthy volunteers Patients affected by acute neuromuscular pathology and starting weaning from invasive ventilation (Guillain Barré and myasthenia).
Patients affected by neuromuscular pathology and home ventilated in a diurnal and night-way by invasive interface or not (respiratory autonomy of at least 1:00 am).
Number of patients, center:
10 healthy volunteers and 40 patients hospitalized in the intensive care unit or in the home of ventilation unit of the Raymond Poincaré hospital.
Total duration of the study: 19 months
- Conditions
- Respiratory Failure
- Being tested
- healthy volonteers, Free breath monitoring
- Keywords
- neuromuscular disease
- Medical subject headings
- Respiratory Insufficiency, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
healthy volonteersDevice
Also called Visuresp system : wireless inductance plethysmography system
Monitoring respiratory function of both acute and chronic neuromuscular patients during weaning or free breath period.
Free breath monitoringDevice
Also called Visuresp system : wireless inductance plethysmography system
Monitoring respiratory function of both acute and chronic neuromuscular patients during weaning or free breath period.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Free breath monitoring. Correlation between two device for recording parameters of ventilation. Receives: Device: healthy volonteers; Device: Free breath monitoring |
| Chronic patient | Experimental | Free breath monitoring. Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) compared with the recording of the PtCO2 and the SpO2) Receives: Device: healthy volonteers; Device: Free breath monitoring |
| ACUTE PATIENT | Experimental | Free breath monitoring. Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) compared with the recording of the PtCO2 and the SpO2) Receives: Device: healthy volonteers; Device: Free breath monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) detected with regard to the recording of the PtCO2 and the SpO2
Healthy subjects will be recorded for one hour in seated positions 30 minutes and slept 30 min.
Pneumotachograph recording will be realized during 5 minutes at the beginning and at the end of every phase of recording. The computer assuring the reception of the signals being remotely located to estimate of the transmission.
All the patients will be registered in parallel with the VISURESP ® system (RBI Grenoble, France) and the measure of the transcutaneous PCO2 and SpO2(SenTec AG, Therwil, Switzerland) during free breath. The measure beginning 30 minutes before the logout and finishing 30 minutes later.
Acute patients being able to like at least 2 H of free breath will be recorded. A first measure will be made dice that a free breath of at least 2H will be possible, then 3 days later and the day the extubation. Aterial blood gazes will be obtained before reconnection. Chronic patients willbe recorded if able to be disconnected from ventilator for more than 1 hour.
Measured: 1 to 12 hours
Secondary outcomes (3)
Respiratory events in healthy volonteers
Quality of data transmission of respiratory paramaters
Measured: 1h
Respiratory events in chronic Patients
Correlation between the number of event detected by VISURESP ®, the duration of hypercapnie superior to 45 mmHg on the PtCO2 and the gazométrie at the end of free Breath.
Measured: 1-12h
Respiratory events in acute patients
Correlations between the number of events detected by the technology VISURESP ®, the duration of hypercapnie superior to 45 mmHg on the PtCO2 and the success of the extubation (at least 24 a hour)
Measured: 1-12h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionNov 2012
- Study completionJun 2014
Why it stopped: Healthy volonteers study results show that the device is not enough reliable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Collaborators
- Adep Assistance
- Responsible party
- Principal investigator, david orlikowski, Centre d'Investigation Clinique et Technologique 805
- Investigators
- DAVID ORLIKOWSKI, MDPHD, Principal investigator, Cic it 805
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807663
- Sponsor's protocol ID
- 2012-A01280-43
- Acronym
- TELERESP
- Status last verified
- Sep 2014
- First submitted
- 26 Feb 2013
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Modalités pratiques de la ventialtion non invasive en pression positive, au long cours, a domicile, dans les maladies neuromusculaires. Rev Mal Respir 2006;23:S3-S40. Toussaint M, Steens M, Wasteels G, Soudon P. Diurnal ventilation via mouthpiece: survival in end-stage Duchenne patients. Eur Respir J 2006;28(3):549-55. Seneviratne J, Mandrekar J, Wijdicks EF, Rabinstein AA. Predictors of extubation failure in myasthenic crisis. Arch Neurol 2008;65(7):929-33. Prigent H, Orlikowski D, Letilly N, Falaize L, Annane D, Sharshar T, et al. Vital Capacity Versus Maximal Inspiratory Pressure in Patients with Guillain-Barre Syndrome and Myasthenia Gravis. Neurocrit Care. Kohler M, Clarenbach CF, Bahler C, Brack T, Russi EW, Bloch KE. Disability and survival in Duchenne muscular dystrophy. J Neurol Neurosurg Psychiatry 2009;80(3):320-5. Brouillette RT, Morrow AS, Weese-Mayer DE, Hunt CE. Comparison of respiratory inductive plethysmography and thoracic impedance for apnea monitoring. J Pediatr 1987;111(3):377-83. Calabrese P, Besleaga T, Eberhard A, Vovc V, Baconnier P. Respiratory inductance plethysmography is suitable for voluntary hyperventilation test. Conf Proc IEEE Eng Med Biol Soc 2007;2007:1055-7. Eberhard A, Calabrese P, Baconnier P, Benchetrit G. Comparison between the respiratory inductance plethysmography signal derivative and the airflow signal. Adv Exp Med Biol 2001;499:489-94. Redline S, Budhiraja R, Kapur V, Marcus CL, Mateika JH, Mehra R, et al. The scoring of respiratory events in sleep: reliability and validity. J Clin Sleep Med 2007;3(2):169-200.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Dynamic Evaluation Tool in Respiratory Failure by Ambulatory Inductance Plethysmography
- ClinicalTrials.gov ID
- NCT01807663
- Acronym / sponsor ID
- TELERESP / 2012-A01280-43
- Conditions
- Respiratory Failure
- Keywords
- neuromuscular disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Healthy volonteers study results show that the device is not enough reliable
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Collaborators
- Adep Assistance
- Study start
- Nov 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Mar 2013 (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.
Determing optimal time of ventilator disconnection is a challenge for both acute and chronic neuromuscular disease. In one case it is helpful for weanning from ventilator and in the other to optimize daytime ventilation in the most severe patients. The investigators propose to validate a new non invasive tool for monitoring respiratroy parameters in neuromuscular patients in both acute and chronic conditions.
Detailed description
Context:
Mechanical ventilation transformed the prognosis of neuromuscular diseases whether for acute or chronic diseases. The available tools to estimate the severity of respiratory insufficiency and indicate or follow the efficiency of mechanical ventilation are based on blood gazes explorations, tests respiratory function and sleep evaluation.
These tools give either limited information, or are with difficulty applicable to patients heavily handicapped except during hospitalization.
In patients under mechanical ventilation, it is sometimes difficult to know the daily optimal time of ventilation. The respiratory events are not generally recognized and are unspecific (headaches, drowsiness, dyspnoea, etc.) or are identified by blood gazes abnormalities (hypercapnia. In acute setting, treble is going to raise the problem of the weaning of the mechanical ventilation and the optimal moment of the extubation without risking a reintubation.
These problems are identical and concern the evaluation of the degree of ventilatory autonomy for home care. The development of methods estimating this autonomy is thus fundamental.
Objectives: the objective of this project is to validate a non-invasive system for measure and acquisition of respiratory parameters, incorporating a transmission system working by a "wireless" technology allowing the remote monitoring of these patients.
The secondary objectives are to determine the parameters of success of weaning by using the device in neuromuscular patients intubated for respiratory failure in acute setting and to determine the optimal time of free breathing possibilities in patients ventilated in a chronic way at home.
Methods:
After validation of the device on 10 healthy subjects, continuous acquisition of the ventilatory data by means of the Teleresp system compared with measure of the transcutaneous PCO2, of SaO2 and arterial gazometry at the end of free breath trial in 40 acute and chronic neuromuscular patients.
Selection criteria:
Healthy volunteers Patients affected by acute neuromuscular pathology and starting weaning from invasive ventilation (Guillain Barré and myasthenia).
Patients affected by neuromuscular pathology and home ventilated in a diurnal and night-way by invasive interface or not (respiratory autonomy of at least 1:00 am).
Number of patients, center:
10 healthy volunteers and 40 patients hospitalized in the intensive care unit or in the home of ventilation unit of the Raymond Poincaré hospital.
Total duration of the study: 19 months
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Device: healthy volonteers, Device: Free breath monitoringFree breath monitoring. Correlation between two device for recording parameters of ventilation. |
| Chronic patient | Experimental | Device: healthy volonteers, Device: Free breath monitoringFree breath monitoring. Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) compared with the recording of the PtCO2 and the SpO2) |
| ACUTE PATIENT | Experimental | Device: healthy volonteers, Device: Free breath monitoringFree breath monitoring. Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) compared with the recording of the PtCO2 and the SpO2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volonteers Man or woman of more than 18 years Realization of a preliminary medical examination Patient having signed an informed and written consent Major healthy subjects, presenting no chronic pathology or not chronic patients
- Chronic patients Man or woman of more than 18 years Affected by neuromuscular pathology Realization of a preliminary medical examination Patient in the stable state at the time of the study for at least 1 month Ventilated in a not invasive or invasive way in diurnal and night-period. Respiratory autonomy > 1:00 am Patient having signed an informed and written consent
- Acute Patients Man or woman of more than 18 years Affected by syndrome of Guillain blocked in aigue phase having required the invasive ventilation or affected by myasthenia generalized with myasthénique crisis having required the invasive ventilation.
- Realization of a preliminary medical examination Patient in phase of neurological recovery Vital Capacity > 15 ml / kg Respiratory Autonomy > 1:00 am Patient having signed a lit(enlightened) and written consent
Key exclusion criteria (3 listed)
- Healthy volonteers subject refusing to participate in the study subject under guardianship or guardianship Pregnant or breast-feeding Woman
- Chronic patients Patient refusing to participate in the study Patient under guardianship or guardianship Pregnant or breast-feeding Woman Patients ventilated only at night Clinically significant bronchial Dimensions(Congestion) Required by oxygen therapy
- Acute patients Patient refusing to participate in the study Patient or subject under guardianship or guardianship Pregnant or breast-feeding Woman Clinically significant bronchial Dimensions(Congestion) Required by oxygen therapy FIO2 > 40 % PEP > 5 cms H2O State of shock
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 |
|---|---|---|
| healthy volonteersAlso: Visuresp system : wireless inductance plethysmography systemMonitoring respiratory function of both acute and chronic neuromuscular patients during weaning or free breath period. | Device | ACUTE PATIENT, Chronic patient, healthy volunteers |
| Free breath monitoringAlso: Visuresp system : wireless inductance plethysmography systemMonitoring respiratory function of both acute and chronic neuromuscular patients during weaning or free breath period. | Device | ACUTE PATIENT, Chronic patient, healthy volunteers |
Primary outcome
Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) detected with regard to the recording of the PtCO2 and the SpO2
Time frame: 1 to 12 hours
Healthy subjects will be recorded for one hour in seated positions 30 minutes and slept 30 min. Pneumotachograph recording will be realized during 5 minutes at the beginning and at the end of every phase of recording. The computer assuring the reception of the signals being remotely located to estimate of the transmission. All the patients will be registered in parallel with the VISURESP ® system (RBI Grenoble, France) and the measure of the transcutaneous PCO2 and SpO2(SenTec AG, Therwil, Switzerland) during free breath. The measure beginning 30 minutes before the logout and finishing 30 minutes later. Acute patients being able to like at least 2 H of free breath will be recorded. A first measure will be made dice that a free breath of at least 2H will be possible, then 3 days later and the day the extubation. Aterial blood gazes will be obtained before reconnection. Chronic patients willbe recorded if able to be disconnected from ventilator for more than 1 hour.
3 secondary outcomes
Respiratory events in healthy volonteers
Time frame: 1h
Respiratory events in chronic Patients
Time frame: 1-12h
Respiratory events in acute patients
Time frame: 1-12h
Results and safety
The study was stopped early (reason given: Healthy volonteers study results show that the device is not enough reliable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
- BackgroundModalités pratiques de la ventialtion non invasive en pression positive, au long cours, a domicile, dans les maladies neuromusculaires. Rev Mal Respir 2006;23:S3-S40. Toussaint M, Steens M, Wasteels G, Soudon P. Diurnal ventilation via mouthpiece: survival in end-stage Duchenne patients. Eur Respir J 2006;28(3):549-55. Seneviratne J, Mandrekar J, Wijdicks EF, Rabinstein AA. Predictors of extubation failure in myasthenic crisis. Arch Neurol 2008;65(7):929-33. Prigent H, Orlikowski D, Letilly N, Falaize L, Annane D, Sharshar T, et al. Vital Capacity Versus Maximal Inspiratory Pressure in Patients with Guillain-Barre Syndrome and Myasthenia Gravis. Neurocrit Care. Kohler M, Clarenbach CF, Bahler C, Brack T, Russi EW, Bloch KE. Disability and survival in Duchenne muscular dystrophy. J Neurol Neurosurg Psychiatry 2009;80(3):320-5. Brouillette RT, Morrow AS, Weese-Mayer DE, Hunt CE. Comparison of respiratory inductive plethysmography and thoracic impedance for apnea monitoring. J Pediatr 1987;111(3):377-83. Calabrese P, Besleaga T, Eberhard A, Vovc V, Baconnier P. Respiratory inductance plethysmography is suitable for voluntary hyperventilation test. Conf Proc IEEE Eng Med Biol Soc 2007;2007:1055-7. Eberhard A, Calabrese P, Baconnier P, Benchetrit G. Comparison between the respiratory inductance plethysmography signal derivative and the airflow signal. Adv Exp Med Biol 2001;499:489-94. Redline S, Budhiraja R, Kapur V, Marcus CL, Mateika JH, Mehra R, et al. The scoring of respiratory events in sleep: reliability and validity. J Clin Sleep Med 2007;3(2):169-200.
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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.
DAVID ORLIKOWSKI, MDPHD principal investigator
Cic it 805
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing healthy volonteers and Free breath monitoring in people with Respiratory Failure, run by Centre d'Investigation Clinique et Technologique 805 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 26 Sep 2014. 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 was stopped early (reason given: Healthy volonteers study results show that the device is not enough reliable). Results are not available in the source record.
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?
Number of pathological respiratory events (apneas, hypopneas, paradoxical breath) detected with regard to the recording of the PtCO2 and the SpO2 (time frame: 1 to 12 hours). 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 NCT01807663, which also lists 1 linked publication.
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 26 Sep 2014.