Neuromuscular DiseasesMONICANCT03218215
Monitoring Mechanical Assisted Cough
An observational study of Neuromuscular Diseases and Respiratory Complication, run by Corporacion Parc Tauli.
Trial summary
Background Mechanical assistance cough for patients with neuromuscular disorders (NMD) are known, but there is no adaptation model established. Currently is performed subjectively by the physiotherapist following the pressures recommended in the current literature as optimal (±40CmH2O). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuromuscular Diseases, Respiratory Complication
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 31 May 2017
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with NMD who had PFC below 160l/min according to Mechanical insufflation- exsufflation (MI-E ) criteria to assit the cough.
Who may be able to join
- patients with NMD who had PFC below 160l/min according to Mechanical insufflation- exsufflation (MI-E ) criteria to assit the cough.
Who cannot join
- age <18 years,
- patients who had undergone tracheostomy, exacerbated or with psychiatric problems
- patients with relative contraindications (bullous emphysema background, risk of pneumothorax or recent barotrauma).
About this study
Official title: Physiological Study About Advantages of Monitoring Mechanical Assisted Cough
Background Mechanical assistance cough for patients with neuromuscular disorders (NMD) are known, but there is no adaptation model established. Currently is performed subjectively by the physiotherapist following the pressures recommended in the current literature as optimal (±40CmH2O). To check is these pressures are the most optimal pressures to achieve the better peak cough flow (PCF) monitoring cough assist (Mechanical insuffllation-exsuflattion MI-E) maneuvers and analyzing pressure- flow / time curves
Adults with MI-E criteria (PCFbaseline <160 l /min). A pneumotachograph, PeakAnalysis software and nasobucal mask were used to monitor and analyze flow/time curves. Protocol included 9 PCF values in each patient: 1 baseline, 4 related with inspiratory pressure in sequential increase of 10 cmH2O (10 to 40 cmH2O) and 4 adding expiratory pressures (±10 to ±40cmH2O)
Read the detailed description
A cross-sectional observational study was performed with patients with NMD who had PFC below 160l/min according to Mechanical insufflation- exsufflation (MI-E ) criteria to assit the cough.
Exclusion criteria were age <18 years, patients who had undergone tracheostomy, exacerbated or with psychiatric problems and patients with relative contraindications (bullous emphysema background, risk of pneumothorax or recent barotrauma).
MI- E study protocol An original protocol was established to perform treatment assessment with Cough Assitst T70 MI-E device® Phillips Respironics. Protocol based on 9 phases of monitoring cough. First was baseline performed for the patient without mechanical assistance and the others were performed by incremental inspiratory and expiratory pressures (cm H2O). Considering ±40 cmH2O as optimal, it was the maximum at the study. An increase of 10 cm H2O in each phase was made starting with the inspiratory pressure (10 to 40 cm H2O or maximum tolerated). Once the maximum pressure tolerated by the patient was reached, the expiratory pressure was introduced following the same sequence. (-10 to -40 cm H2O or maximum tolerated).
Monitoring MI- E protocol: signals and instrumentation As a signal acquisition system, an external polygraph (16Sp Powerlab, ADInstruments, Sydney, Australia), equipped with a pressure transducer (1050 model) and a pneumotachograph (S300, instrumental dead space _ 70 mL, resistance _ 0.0018 cm H2O/L/s) was connected to MI-E device. Sampling frequency was set to 200 Hz, and the polygraph was connected to a personal computer equipped with Chart 7.0 software for Windows.
Signal processing and analysis of waveforms, pressure-time and flow-time, were performed by this software that allowed calculate Peak cough flow maximum in each phase and checking possible respiratory events what could happen during the therapy.
Parameters measured and Other assessments PCFMaximal (max) (l /min) achieved by the patient measured thorough Peak Analysis software, related to Maximal Inspiratory pressure (MIP) and Maximal Expiratory pressure (MEP) measured by cmH2O, and Phase Number like a combination of both outcomes. All phases recorded 3 respiratory cycles with cough and the best was used for the analysis.
Oxygen saturation (SpO2%)and heart rate (bpm), before and after of each phase to control patient status. Patients with Amyotrophic Lateral Sclerosis (ALS) were assessed using th ALS Functional Rating Scale revised (ALSFRS-r) (cita). Bulbar impairment score was evaluated from the ALSFRS-r, from where the items of speech and swallowing were calculated.
- Conditions
- Neuromuscular Diseases, Respiratory Complication
- Keywords
- cough assits
- Medical subject headings
- Neuromuscular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak cough flow (max): PCFmax (l/min)
Peak cough flow maximum achieve by the patient. This outcome will be related with outcomes pressures.
Measured: Day 1
Max Inspiratory Pressure: MIP (cmH2O)
Inspiratory pressure in phase of protocol with the best peak cough flow achieve
Measured: Day 1
Max Expiratory Pressure:MEP (cmH2O)
Expiratory pressure in phase of protocol with the best peak cough flow achieve
Measured: Day 1
Secondary outcomes (5)
Oxygen Saturation pre protocol
Oxygen saturation pre protocol measured by %
Measured: Day 1
Oxygen Saturation post protocol
Oxygen saturation post protocol measured by %
Measured: Day 1
ALSFR scale
scale that measure level of disease progression in ALS ( amiotrophic Lateral Sclerosis) main pathology of study
Measured: Day 1
Pathology
ALS, other neumuscular disorders
Measured: Day 1
PCF at baseline (l/min)
PCF achieve before the protocol.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start1 May 2015
- Primary completion26 May 2015
- Study completion31 May 2017
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.
- 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
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacio Catalana de Pneumologia
- Responsible party
- Principal investigator, Cristina Lalmolda-Puyol, Corporacion Parc Tauli
- Investigators
- Manel Lujan, MD, Study director, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218215
- Sponsor's protocol ID
- SOCAP-2015
- Acronym
- MONICA
- Status last verified
- Jul 2017
- First submitted
- 7 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Study About Advantages of Monitoring Mechanical Assisted Cough
- ClinicalTrials.gov ID
- NCT03218215
- Acronym / sponsor ID
- MONICA / SOCAP-2015
- Conditions
- Neuromuscular Diseases, Respiratory Complication
- Keywords
- cough assits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Fundacio Catalana de Pneumologia
- Study start
- 1 May 2015 (actual)
- Primary completion
- 26 May 2015 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 14 Jul 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.
Background Mechanical assistance cough for patients with neuromuscular disorders (NMD) are known, but there is no adaptation model established. Currently is performed subjectively by the physiotherapist following the pressures recommended in the current literature as optimal (±40CmH2O). To check is these pressures are the most optimal pressures to achieve the better peak cough flow (PCF) monitoring cough assist (Mechanical insuffllation-exsuflattion MI-E) maneuvers and analyzing pressure- flow / time curves
Adults with MI-E criteria (PCFbaseline <160 l /min). A pneumotachograph, PeakAnalysis software and nasobucal mask were used to monitor and analyze flow/time curves. Protocol included 9 PCF values in each patient: 1 baseline, 4 related with inspiratory pressure in sequential increase of 10 cmH2O (10 to 40 cmH2O) and 4 adding expiratory pressures (±10 to ±40cmH2O)
Detailed description
A cross-sectional observational study was performed with patients with NMD who had PFC below 160l/min according to Mechanical insufflation- exsufflation (MI-E ) criteria to assit the cough.
Exclusion criteria were age <18 years, patients who had undergone tracheostomy, exacerbated or with psychiatric problems and patients with relative contraindications (bullous emphysema background, risk of pneumothorax or recent barotrauma).
MI- E study protocol An original protocol was established to perform treatment assessment with Cough Assitst T70 MI-E device® Phillips Respironics. Protocol based on 9 phases of monitoring cough. First was baseline performed for the patient without mechanical assistance and the others were performed by incremental inspiratory and expiratory pressures (cm H2O). Considering ±40 cmH2O as optimal, it was the maximum at the study. An increase of 10 cm H2O in each phase was made starting with the inspiratory pressure (10 to 40 cm H2O or maximum tolerated). Once the maximum pressure tolerated by the patient was reached, the expiratory pressure was introduced following the same sequence. (-10 to -40 cm H2O or maximum tolerated).
Monitoring MI- E protocol: signals and instrumentation As a signal acquisition system, an external polygraph (16Sp Powerlab, ADInstruments, Sydney, Australia), equipped with a pressure transducer (1050 model) and a pneumotachograph (S300, instrumental dead space _ 70 mL, resistance _ 0.0018 cm H2O/L/s) was connected to MI-E device. Sampling frequency was set to 200 Hz, and the polygraph was connected to a personal computer equipped with Chart 7.0 software for Windows.
Signal processing and analysis of waveforms, pressure-time and flow-time, were performed by this software that allowed calculate Peak cough flow maximum in each phase and checking possible respiratory events what could happen during the therapy.
Parameters measured and Other assessments PCFMaximal (max) (l /min) achieved by the patient measured thorough Peak Analysis software, related to Maximal Inspiratory pressure (MIP) and Maximal Expiratory pressure (MEP) measured by cmH2O, and Phase Number like a combination of both outcomes. All phases recorded 3 respiratory cycles with cough and the best was used for the analysis.
Oxygen saturation (SpO2%)and heart rate (bpm), before and after of each phase to control patient status. Patients with Amyotrophic Lateral Sclerosis (ALS) were assessed using th ALS Functional Rating Scale revised (ALSFRS-r) (cita). Bulbar impairment score was evaluated from the ALSFRS-r, from where the items of speech and swallowing were calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with NMD who had PFC below 160l/min according to Mechanical insufflation- exsufflation (MI-E ) criteria to assit the cough.
Key inclusion criteria (1 listed)
- patients with NMD who had PFC below 160l/min according to Mechanical insufflation- exsufflation (MI-E ) criteria to assit the cough.
Key exclusion criteria (3 listed)
- age <18 years,
- patients who had undergone tracheostomy, exacerbated or with psychiatric problems
- patients with relative contraindications (bullous emphysema background, risk of pneumothorax or recent barotrauma).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak cough flow (max): PCFmax (l/min)
Time frame: Day 1
Peak cough flow maximum achieve by the patient. This outcome will be related with outcomes pressures.
Max Inspiratory Pressure: MIP (cmH2O)
Time frame: Day 1
Inspiratory pressure in phase of protocol with the best peak cough flow achieve
Max Expiratory Pressure:MEP (cmH2O)
Time frame: Day 1
Expiratory pressure in phase of protocol with the best peak cough flow achieve
5 secondary outcomes
Oxygen Saturation pre protocol
Time frame: Day 1
Oxygen Saturation post protocol
Time frame: Day 1
ALSFR scale
Time frame: Day 1
Pathology
Time frame: Day 1
PCF at baseline (l/min)
Time frame: Day 1
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 18 Jul 2017.
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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.
Manel Lujan, MD study director
Corporacion Parc Tauli
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases and Respiratory Complication, run by Corporacion Parc Tauli.
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 1 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 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Peak cough flow (max): PCFmax (l/min) (time frame: Day 1). The study lists 3 primary outcomes in all. 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 18 Jul 2017.