Neuromuscular DiseasesEXSUFLOWNCT03355105
Comparison of Two Methods of Adjusting the Mechanical In-Exsuflation in Neuromuscular Adult Patients
A study testing Objective adjustment of the MI/E exsuflation pressure and evaluation of cough effort and Subjective adjustment of the MI/E exsuflation pressure and evaluation of cough effort in people with Neuromuscular Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In the context of neuromuscular diseases, the weakness of the respiratory muscles makes difficult to manage periods of congestion due to a less effective cough. It exposes the patient to bronchial superinfections that may require hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- Objective adjustment of the MI/E exsuflation pressure and evaluation of cough effort and Subjective adjustment of the MI/E exsuflation pressure and evaluation of cough effort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 7 Mar 2019to 24 Dec 2024
- 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
- Aged ≥18 years
- Neuromuscular pathology
- Coughing aid information: DEPT <180 l / min
- In stable condition and without bulk
- Good understanding and cognition to follow the instructions and to inform the EVA
- Affiliated to a Sickness Insurance Plan or entitled
- Signed of informed consent
Who cannot join
- Pregnant woman
- Person under guardianship
- Inability to cooperate and / or communicate
- Acute decompensated organ
- Patient with following contraindications to mechanical in-exsufflation (MI-E) devices:
- pneumothorax
Show all 14Show fewer
- pneumomediastinum
- pulmonary emphysema
- hemoptysis
- pleurisy
- nausea
- obstructive pulmonary disease or asthma
- recent lobectomy of the lung
- intracranial pressure
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Physiology and Functional Explorations, Raymond Poincaré Hospital
Garches, Hauts-de-Seine, 92380
About this study
In the context of neuromuscular diseases, the weakness of the respiratory muscles makes difficult to manage periods of congestion due to a less effective cough. It exposes the patient to bronchial superinfections that may require hospitalization. The use of cough assistance is therefore essential in order to avoid acute situations such as bronchial superinfections. Mechanical Insuflation-Exsufflation (MI / E) is an instrumental technique commonly used by therapists in a hospital or at the patient's home in order to facilitate the airway mucus clearance. The choice of the pressure settings of the IM / E is a decisive point because it conditions the effectiveness of the generated cough. It'is important to take into account the presence of any collapse in the use of IM / E in order to ensure the most effective cough given by the patient. Actually, except the common impression of the physiotherapist and the patient, there is no "simple" way for detecting and objectifying the threshold of collapse in the upper airways.
The aim of this study is to compare two modalities for the regulation of the level of the MI-E exsufflation, taking into account the presence of a collapse: a subjective "S" adjustment based on the clinical judgment of the therapist and the patient and an objective "O" adjustment based on the flow-volume curve generated during the cough.
Read the detailed description
This is a bicentric, prospective crossover, randomized, open label trial. The study will focus on 50 adult patients with stable neuromuscular conditions, outside the congestion period requiring cough help.
Patients will be recruited from among the neuromuscular disease patients followed for their respiratory management in the home ventilation unit of the Raymond Poincaré Hospital Intensive care Unit or in the Aincourt Neurological Rehabilitation Service attached to the Vexin Intercommunal Hospital Group.
The cough help performed with the MI / E will be evaluated according to two conditions of adjustment of the exsufflation pressure: a subjective adjustment (modality S) and an objective adjustment (modality O), whose order will be randomized to control a phenomenon of tiredness causing confusion.
A respiratory technician and two therapists will participate to the protocol. The therapist "clinician" and "evaluator" role will be defined by a draw.
The protocol will take place during the same day of hospitalization in two stages:
- T0: validation of the eligibility criteria and inclusion of patients in the study.
- T1: evaluation of coughing performance according to the two modes of exsufflation pressure adjustment. Adjustment modality "S" according to the clinical impression of the "clinician" therapist and the patient, and the "Cough Peak Expiratory Flow" measured by the MI / E. Adjustment modality "O": according to the analysis of the flow / volume curve measured using a spirometer and a pneumotachograph.
- Conditions
- Neuromuscular Diseases
- Being tested
- Objective adjustment of the MI/E exsuflation pressure and evaluation of cough effort, Subjective adjustment of the MI/E exsuflation pressure and evaluation of cough effort
- Keywords
- Neuromuscular disease
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Objective adjustment of the MI/E exsuflation pressure and evaluation of cough effortOther
The exsufflation pressures will be progressively increased starting from -20 cmH2O with 10 cmH2O increments up. 3 coughing operations will be realised for each level, until obtention of 10% of AUC decrease or a PCF collapse of at least 10% over the last 2 levels and without exceeding -70 cmH2O. The selected landing will be the one allowing the largest PCF without presence of collapse. An intermediate bearing between 2 bearings may be tested in order to approach an optimum adjustment threshold less than 5 cmH2O.
Subjective adjustment of the MI/E exsuflation pressure and evaluation of cough effortOther
The exsufflation pressures will be gradually increased from -20 cmH2O, with 10 cmH2O increments up to a maximum of -70 cmH2O. The selected level will be the one selected both by the patient and the "clinician" therapist and considered as making it possible to obtain the most effective cough according to the return of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Objective adjustment of the MI/E exsuflation pressure | Experimental | Objective adjustment of the MI/E exsuflation pressure based on the flow-volume curve generated during the cough. Receives: Other: Objective adjustment of the MI/E exsuflation pressure and evaluation of cough effort |
| Subjective adjustment of the MI/E exsuflation pressure | Active comparator | Subjective adjustment of the MI/E exsuflation pressure based on the clinical judgment of the therapist and the patient. Receives: Other: Subjective adjustment of the MI/E exsuflation pressure and evaluation of cough effort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC) Flow Volume
The primary endpoint is the Area Under Curve (AUC) Flow Volume during the cough expiratory phase.
To compare the cough effectiveness obtained according to the current modalities of the MI / E exsuflation pressure setting to that resulting from an adjustment based on the analysis of the flow-volume curve.
Measured: At baseline
Secondary outcomes (5)
Peak Cough Flow (PCF)
The Peak Cough Flow (PCF) : will be measured with a spirometer connected in series on the circuit of MI-E. Will be checked: whether the best AUC and the best PCF (regardless of the modality) occur during the same level of depression.
Measured: At baseline
Evaluate the association between the peak cough flow (PCF) generated and the subjective criteria
Measured: At baseline
Subjective Therapist Cough Effectiveness
These measurements will be performed using an Analogical Visual Scale.
Measured: At baseline
Subjective Patient Cough Effectiveness
These measurements will be performed using an Analogical Visual Scale.
Measured: At baseline
Respiratory comfort
The respiratory comfort of the patient during the effort of cough. These measurements will be performed using an Analogical Visual Scale.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start7 Mar 2019
- Primary completion23 Dec 2024 (estimated)
- Study completion24 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric LOFASO, MD, PhD, Study chair, Department of Physiology and Functional Explorations, Raymond Poincaré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355105
- Sponsor's protocol ID
- K160910J
- Other IDs
- 2017-A01794-49
- Acronym
- EXSUFLOW
- Status last verified
- Jun 2024
- First submitted
- 22 Nov 2017
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Methods of Adjusting the Mechanical In-Exsuflation in Neuromuscular Adult Patients
- ClinicalTrials.gov ID
- NCT03355105
- Acronym / sponsor ID
- EXSUFLOW / K160910J
- Conditions
- Neuromuscular Diseases
- Keywords
- Neuromuscular disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 23 Dec 2024 (estimated)
- Study completion
- 24 Dec 2024 (estimated)
- First posted
- 28 Nov 2017 (actual)
- 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.
In the context of neuromuscular diseases, the weakness of the respiratory muscles makes difficult to manage periods of congestion due to a less effective cough. It exposes the patient to bronchial superinfections that may require hospitalization. The use of cough assistance is therefore essential in order to avoid acute situations such as bronchial superinfections. Mechanical Insuflation-Exsufflation (MI / E) is an instrumental technique commonly used by therapists in a hospital or at the patient's home in order to facilitate the airway mucus clearance. The choice of the pressure settings of the IM / E is a decisive point because it conditions the effectiveness of the generated cough. It'is important to take into account the presence of any collapse in the use of IM / E in order to ensure the most effective cough given by the patient. Actually, except the common impression of the physiotherapist and the patient, there is no "simple" way for detecting and objectifying the threshold of collapse in the upper airways.
The aim of this study is to compare two modalities for the regulation of the level of the MI-E exsufflation, taking into account the presence of a collapse: a subjective "S" adjustment based on the clinical judgment of the therapist and the patient and an objective "O" adjustment based on the flow-volume curve generated during the cough.
Detailed description
This is a bicentric, prospective crossover, randomized, open label trial. The study will focus on 50 adult patients with stable neuromuscular conditions, outside the congestion period requiring cough help.
Patients will be recruited from among the neuromuscular disease patients followed for their respiratory management in the home ventilation unit of the Raymond Poincaré Hospital Intensive care Unit or in the Aincourt Neurological Rehabilitation Service attached to the Vexin Intercommunal Hospital Group.
The cough help performed with the MI / E will be evaluated according to two conditions of adjustment of the exsufflation pressure: a subjective adjustment (modality S) and an objective adjustment (modality O), whose order will be randomized to control a phenomenon of tiredness causing confusion.
A respiratory technician and two therapists will participate to the protocol. The therapist "clinician" and "evaluator" role will be defined by a draw.
The protocol will take place during the same day of hospitalization in two stages:
- T0: validation of the eligibility criteria and inclusion of patients in the study.
- T1: evaluation of coughing performance according to the two modes of exsufflation pressure adjustment. Adjustment modality "S" according to the clinical impression of the "clinician" therapist and the patient, and the "Cough Peak Expiratory Flow" measured by the MI / E. Adjustment modality "O": according to the analysis of the flow / volume curve measured using a spirometer and a pneumotachograph.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Objective adjustment of the MI/E exsuflation pressure | Experimental | Other: Objective adjustment of the MI/E exsuflation pressure and evaluation of cough effortObjective adjustment of the MI/E exsuflation pressure based on the flow-volume curve generated during the cough. |
| Subjective adjustment of the MI/E exsuflation pressure | Active comparator | Other: Subjective adjustment of the MI/E exsuflation pressure and evaluation of cough effortSubjective adjustment of the MI/E exsuflation pressure based on the clinical judgment of the therapist and the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18 years
- Neuromuscular pathology
- Coughing aid information: DEPT <180 l / min
- In stable condition and without bulk
- Good understanding and cognition to follow the instructions and to inform the EVA
Key exclusion criteria (14 listed)
- Pregnant woman
- Person under guardianship
- Inability to cooperate and / or communicate
- Acute decompensated organ
- Patient with following contraindications to mechanical in-exsufflation (MI-E) devices:
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 |
|---|---|---|
| Objective adjustment of the MI/E exsuflation pressure and evaluation of cough effortThe exsufflation pressures will be progressively increased starting from -20 cmH2O with 10 cmH2O increments up. 3 coughing operations will be realised for each level, until obtention of 10% of AUC decrease or a PCF collapse of at least 10% over the last 2 levels and without exceeding -70 cmH2O. The selected landing will be the one allowing the largest PCF without presence of collapse. An intermediate bearing between 2 bearings may be tested in order to approach an optimum adjustment threshold less than 5 cmH2O. | Other | Objective adjustment of the MI/E exsuflation pressure |
| Subjective adjustment of the MI/E exsuflation pressure and evaluation of cough effortThe exsufflation pressures will be gradually increased from -20 cmH2O, with 10 cmH2O increments up to a maximum of -70 cmH2O. The selected level will be the one selected both by the patient and the "clinician" therapist and considered as making it possible to obtain the most effective cough according to the return of the patient. | Other | Subjective adjustment of the MI/E exsuflation pressure |
Primary outcome
Area Under Curve (AUC) Flow Volume
Time frame: At baseline
The primary endpoint is the Area Under Curve (AUC) Flow Volume during the cough expiratory phase. To compare the cough effectiveness obtained according to the current modalities of the MI / E exsuflation pressure setting to that resulting from an adjustment based on the analysis of the flow-volume curve.
5 secondary outcomes
Peak Cough Flow (PCF)
Time frame: At baseline
Evaluate the association between the peak cough flow (PCF) generated and the subjective criteria
Time frame: At baseline
Subjective Therapist Cough Effectiveness
Time frame: At baseline
Subjective Patient Cough Effectiveness
Time frame: At baseline
Respiratory comfort
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Frédéric LOFASO, MD, PhD study chair
Department of Physiology and Functional Explorations, Raymond Poincaré Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Objective adjustment of the MI/E exsuflation pressure and evaluation of cough effort and Subjective adjustment of the MI/E exsuflation pressure and evaluation of cough effort in people with Neuromuscular Diseases, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. 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?
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?
Area Under Curve (AUC) Flow Volume (time frame: At baseline). 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 11 Jun 2024.