Monitoring Mechanical Assisted Cough

Neuromuscular Diseases Clinical Trial

— MONICA  

Official title:

Physiological Study About Advantages of Monitoring Mechanical Assisted Cough

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218215
• Other study ID #: SOCAP-2015
• Status: Completed
• Phase: N/A
• First received: July 7, 2017
• Last updated: July 14, 2017
• Start date: May 1, 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: July 2017
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 31, 2017
• Est. primary completion date: May 26, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Neuromuscular Diseases
• Respiratory Complication

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Fundacio Catalana de Pneumologia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak cough flow (max): PCFmax (l/min)	Peak cough flow maximum achieve by the patient. This outcome will be related with outcomes pressures.	Day 1
Primary	Max Inspiratory Pressure: MIP (cmH2O)	Inspiratory pressure in phase of protocol with the best peak cough flow achieve	Day 1
Primary	Max Expiratory Pressure:MEP (cmH2O)	Expiratory pressure in phase of protocol with the best peak cough flow achieve	Day 1
Secondary	Oxygen Saturation pre protocol	Oxygen saturation pre protocol measured by %	Day 1
Secondary	Oxygen Saturation post protocol	Oxygen saturation post protocol measured by %	Day 1
Secondary	ALSFR scale	scale that measure level of disease progression in ALS ( amiotrophic Lateral Sclerosis) main pathology of study	Day 1
Secondary	Pathology	ALS, other neumuscular disorders	Day 1
Secondary	PCF at baseline (l/min)	PCF achieve before the protocol.	Day 1