Neuromuscular DiseasesMIEPCFNCT04935905
Accuracy of Peak Cough Flow Measurements Using a Mechanical Insufflator-exsufflator
An observational study of Neuromuscular Diseases, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The primary aim of this study is to evaluate the agreement of MIE devices measurement of MIE assisted peak cough flow (PCF) compared with a pneumotachographs during usual MIE care. This will be the first study to do this through range of MIE pressures and include patients who are receiving MIE via a tracheostomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- Mechanical Insufflator-Exsufflator
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Dec 2020to 1 Sep 2021
- Phase
- Observational
- 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
- Women only
- Adult, Older adult
Study population: Patient with neuromuscular related respiratory failure and receiving MIE as part of their usual care
Who may be able to join
- Patients with neuromuscular disease-related respiratory failure and are receiving MIE as part of their usual care
- Patients who are clinical stable and documented as such by the supervising clinician
- Patients who are cognitively intact and have the capacity able to provide informed consent
Who cannot join
- Pregnancy
- Aged <18
- Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St. Thomas NHS Foundation Trust
London, SE1 7EH
About this study
Official title: Accuracy of Peak Cough Flow Measurements Using a Mechanical Insufflator-exsufflator in Patients With Neuromuscular Disease: A Single Centre Prospective Observational Study
The primary aim of this study is to evaluate the agreement of MIE devices measurement of MIE assisted peak cough flow (PCF) compared with a pneumotachographs during usual MIE care. This will be the first study to do this through range of MIE pressures and include patients who are receiving MIE via a tracheostomy. It will also aim to evaluate the intra-subject repeatability of measures for patients who receive more than one MIE cycle as part of their usual care. It will be the first to measure MIE assisted PCF contemporaneously during intervention using the gold standard pneumotachograph. This will inform treatment effect size and the efficacy of usual practice MIE in augmenting PCF measurements above critical cut off values for effective cough and secretion clearance.
Finally the study will also aim to understand how patients perceive the impact of MIE in clearing secretions from their chest by asking them to rate presence of chest secretions pre and post intervention using a visual analogue scale (VAS)
Read the detailed description
Patients with a neuromuscular disease (NMD) lose strength in their breathing muscles which leads to an inability to generate an effective cough. Peak Cough Flow (PCF) is a simple objective measure of cough and is the recommended measure in patients with NMD. Critical peak cough flow values are used to evaluate cough, these include PCF less than 160 L/min to indicate an ineffective cough, PCF between 161- 270 to indicate an impaired cough and PCF greater than 270 L/min to indicate an effective cough. Mechanical insufflator- exsufflator (MIE) devices more commonly known as 'cough assist' devices have an inbuilt measure of PCF however they aren't currently recommended for use to due to limited information available regarding their accuracy. This will be a single centre prospective observational study. Once patients have consented to participate in the study, they will be visited once on the unit during their admission by the researcher with the visit lasting approximately an hour.
During the visit they will receive their usual care MIE with a pneumotachograph fitted into the circuit. The primary outcome is the agreement of MIE assisted PCF measures between the MIE device and pneumotachograph. Before and after the intervention the patient will be asked to rate the presence of mucous in their lungs using a visual analogue scale.
The following data will be recorded
- Neuromuscular diagnosis
- Age, height, weight,
- Comorbidities
- Hospital length of stay (Days)
- Ventilation dependency(hours/Day)
- Bronchodilator and/or mucolytic medications
- Vital observations (heart rate, blood pressure, oxygen saturations)
- Method of MIE delivery (mask or tracheostomy)
- Tracheostomy size, type and brand
- Bulbar function if available (Laryngoscope)
- Spirometry - Forced Expired Volume in 1 second (FEV1), Forced Vital Capacity (FVC), (from clinical notes)
- Voluntary PCF (collected from patient by researcher)
- MIE Mode (collected from device by researcher)
- MIE Total number cycle repeats (collected from device by researcher)
- MIE device Inspiratory pressure (collected from device by researcher)
- MIE inspiratory pressure at interface (Pressure transducer)
- MIE inspiratory time (collected from device by researcher)
- MIE peak inspiratory Flow (from device by researcher)
- MIE device expiratory pressure (collected from device by researcher)
- MIE expiratory pressure at interface (Pressure transducer)
- MIE Expiratory time (collected from device by researcher)
- MIE Assisted PCF Pneumotachograph (From patient by researcher)
- MIE Assisted PCF MIE (From patient by researcher)
- Visual Analogue Scale regarding secretion presence pre and post MIE (from patient by researcher)
- Conditions
- Neuromuscular Diseases
- Being tested
- Mechanical Insufflator-Exsufflator
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Insufflator-ExsufflatorDevice
This device augments a cough by applying a positive pressure via the upper airway or tracheostomy to increase lung volume to maximal inspiratory capacity, followed by a rapid and quick change to negative pressure to increase expiratory flow and simulate normal cough mechanism
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement of Peak Cough Flow between MIE and pneumotachograph.
Peak Cough Flow measure the peak flow of expired air during the exsufflation phase of cough or MIE assisted cough
Measured: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Secondary outcomes (5)
Visual Analogue Scale
Patients will be asked regarding their perceived presence of chest secretions pre and post and post intervention using the visual analogue scale. The scale ranges from 0 to 10 with 10 being the highest perceived score.
Measured: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Treatment effect size of PCF during usual MIE care
Will compared baseline voluntary PCF to MIE assisted PCF
Measured: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Exploratory analysis of MIE Pressure and PCF
Exploratory analysis of the correlation between MIE Pressure with PCF and cough function will be performed using chi square, correlation and logistic regression as appropriate.
Measured: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Exploratory analysis of MIE inspiratory Volume and PCF
Exploratory analysis of the correlation between MIE inspiratory volume with PCF and cough function will be performed using chi square, correlation and logistic regression as appropriate.
Measured: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Intra-subject variance of repeated PCF measures
For patient receiving more than one cycle of MIE during their usual care, the repeated PCF measures taken by MIE and Pneumotachograph and variance of measures evaluated
Measured: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start4 Dec 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
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 Guy's and St Thomas' NHS Foundation TrustThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leyla Osman, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935905
- Sponsor's protocol ID
- 272851
- Acronym
- MIEPCF
- Status last verified
- Jan 2022
- First submitted
- 5 Feb 2020
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Peak Cough Flow Measurements Using a Mechanical Insufflator-exsufflator in Patients With Neuromuscular Disease: A Single Centre Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04935905
- Acronym / sponsor ID
- MIEPCF / 272851
- Conditions
- Neuromuscular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 23 Jun 2021 (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.
The primary aim of this study is to evaluate the agreement of MIE devices measurement of MIE assisted peak cough flow (PCF) compared with a pneumotachographs during usual MIE care. This will be the first study to do this through range of MIE pressures and include patients who are receiving MIE via a tracheostomy. It will also aim to evaluate the intra-subject repeatability of measures for patients who receive more than one MIE cycle as part of their usual care. It will be the first to measure MIE assisted PCF contemporaneously during intervention using the gold standard pneumotachograph. This will inform treatment effect size and the efficacy of usual practice MIE in augmenting PCF measurements above critical cut off values for effective cough and secretion clearance.
Finally the study will also aim to understand how patients perceive the impact of MIE in clearing secretions from their chest by asking them to rate presence of chest secretions pre and post intervention using a visual analogue scale (VAS)
Detailed description
Patients with a neuromuscular disease (NMD) lose strength in their breathing muscles which leads to an inability to generate an effective cough. Peak Cough Flow (PCF) is a simple objective measure of cough and is the recommended measure in patients with NMD. Critical peak cough flow values are used to evaluate cough, these include PCF less than 160 L/min to indicate an ineffective cough, PCF between 161- 270 to indicate an impaired cough and PCF greater than 270 L/min to indicate an effective cough. Mechanical insufflator- exsufflator (MIE) devices more commonly known as 'cough assist' devices have an inbuilt measure of PCF however they aren't currently recommended for use to due to limited information available regarding their accuracy. This will be a single centre prospective observational study. Once patients have consented to participate in the study, they will be visited once on the unit during their admission by the researcher with the visit lasting approximately an hour.
During the visit they will receive their usual care MIE with a pneumotachograph fitted into the circuit. The primary outcome is the agreement of MIE assisted PCF measures between the MIE device and pneumotachograph. Before and after the intervention the patient will be asked to rate the presence of mucous in their lungs using a visual analogue scale.
The following data will be recorded
- Neuromuscular diagnosis
- Age, height, weight,
- Comorbidities
- Hospital length of stay (Days)
- Ventilation dependency(hours/Day)
- Bronchodilator and/or mucolytic medications
- Vital observations (heart rate, blood pressure, oxygen saturations)
- Method of MIE delivery (mask or tracheostomy)
- Tracheostomy size, type and brand
- Bulbar function if available (Laryngoscope)
- Spirometry - Forced Expired Volume in 1 second (FEV1), Forced Vital Capacity (FVC), (from clinical notes)
- Voluntary PCF (collected from patient by researcher)
- MIE Mode (collected from device by researcher)
- MIE Total number cycle repeats (collected from device by researcher)
- MIE device Inspiratory pressure (collected from device by researcher)
- MIE inspiratory pressure at interface (Pressure transducer)
- MIE inspiratory time (collected from device by researcher)
- MIE peak inspiratory Flow (from device by researcher)
- MIE device expiratory pressure (collected from device by researcher)
- MIE expiratory pressure at interface (Pressure transducer)
- MIE Expiratory time (collected from device by researcher)
- MIE Assisted PCF Pneumotachograph (From patient by researcher)
- MIE Assisted PCF MIE (From patient by researcher)
- Visual Analogue Scale regarding secretion presence pre and post MIE (from patient by researcher)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patient with neuromuscular related respiratory failure and receiving MIE as part of their usual care
Key inclusion criteria (3 listed)
- Patients with neuromuscular disease-related respiratory failure and are receiving MIE as part of their usual care
- Patients who are clinical stable and documented as such by the supervising clinician
- Patients who are cognitively intact and have the capacity able to provide informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Aged <18
- Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
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 |
|---|---|---|
| Mechanical Insufflator-ExsufflatorThis device augments a cough by applying a positive pressure via the upper airway or tracheostomy to increase lung volume to maximal inspiratory capacity, followed by a rapid and quick change to negative pressure to increase expiratory flow and simulate normal cough mechanism | Device | – |
Primary outcome
Agreement of Peak Cough Flow between MIE and pneumotachograph.
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Peak Cough Flow measure the peak flow of expired air during the exsufflation phase of cough or MIE assisted cough
5 secondary outcomes
Visual Analogue Scale
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Treatment effect size of PCF during usual MIE care
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Exploratory analysis of MIE Pressure and PCF
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Exploratory analysis of MIE inspiratory Volume and PCF
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
Intra-subject variance of repeated PCF measures
Time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year
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 26 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
Leyla Osman principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 3 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: finished, as of the sponsor's last update on 26 Jan 2022. 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 United Kingdom. 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?
Agreement of Peak Cough Flow between MIE and pneumotachograph. (time frame: Data will be collected at the point of recruitment to the study and then be reported within 1 year). 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 26 Jan 2022.