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Neuromuscular DiseasesMONICANCT03218215

Monitoring Mechanical Assisted Cough

An observational study of Neuromuscular Diseases and Respiratory Complication, run by Corporacion Parc Tauli.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

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.

  1. 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

  2. Max Inspiratory Pressure: MIP (cmH2O)

    Inspiratory pressure in phase of protocol with the best peak cough flow achieve

    Measured: Day 1

  3. Max Expiratory Pressure:MEP (cmH2O)

    Expiratory pressure in phase of protocol with the best peak cough flow achieve

    Measured: Day 1

Secondary outcomes (5)
  1. Oxygen Saturation pre protocol

    Oxygen saturation pre protocol measured by %

    Measured: Day 1

  2. Oxygen Saturation post protocol

    Oxygen saturation post protocol measured by %

    Measured: Day 1

  3. ALSFR scale

    scale that measure level of disease progression in ALS ( amiotrophic Lateral Sclerosis) main pathology of study

    Measured: Day 1

  4. Pathology

    ALS, other neumuscular disorders

    Measured: Day 1

  5. 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.

  1. First posted14 Jul 2017
  2. Study start1 May 2015
  3. Primary completion26 May 2015
  4. Study completion31 May 2017

Resources

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)
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

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.

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