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临床试验/NCT03218215
NCT03218215已完成不适用

Physiological Study About Advantages of Monitoring Mechanical Assisted Cough

Corporacion Parc Tauli0 个研究点目标入组 21 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
主要终点
Peak cough flow (max): PCFmax (l/min)

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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).

结局指标

主要结局

Peak cough flow (max): PCFmax (l/min)

时间窗: Day 1

Peak cough flow maximum achieve by the patient. This outcome will be related with outcomes pressures.

Max Expiratory Pressure:MEP (cmH2O)

时间窗: Day 1

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

Max Inspiratory Pressure: MIP (cmH2O)

时间窗: Day 1

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

次要结局

  • PCF at baseline (l/min)(Day 1)
  • Oxygen Saturation pre protocol(Day 1)
  • Pathology(Day 1)
  • ALSFR scale(Day 1)
  • Oxygen Saturation post protocol(Day 1)

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristina Lalmolda-Puyol

Physiotherapist

Corporacion Parc Tauli

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