Clinical trial NCT03218215: Monitoring Mechanical Assisted Cough
Official title: Physiological Study About Advantages of Monitoring Mechanical Assisted Cough
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases
Respiratory Complication
Keywords: cough assits
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
Collaborators: name: Fundacio Catalana de Pneumologia
First posted: 2017-07-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with NMD who had PFC below 160l/min according to Mechanical insufflation- exsufflation (MI-E ) criteria to assit the cough.

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* patients with NMD who had PFC below 160l/min according to Mechanical insufflation- exsufflation (MI-E ) criteria to assit the cough.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Peak cough flow (max): PCFmax (l/min)
timeFrame: Day 1
measure: Max Inspiratory Pressure: MIP (cmH2O)
timeFrame: Day 1
measure: Max Expiratory Pressure:MEP (cmH2O)
timeFrame: Day 1
Secondary outcomes:
measure: Oxygen Saturation pre protocol
timeFrame: Day 1
measure: Oxygen Saturation post protocol
timeFrame: Day 1
measure: ALSFR scale
timeFrame: Day 1
measure: Pathology
timeFrame: Day 1
measure: PCF at baseline (l/min)
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Corporacion Parc Tauli
name: Manel Lujan, MD
role: STUDY_DIRECTOR
References: