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临床试验/NCT02765360
NCT02765360已完成不适用

Changes in Lung Ventilation With Different Modes of Non-invasive Ventilation in COPD and OHS Patients

Guy's and St Thomas' NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Characteristics seen during ventilation in different modes of ventilation

研究概览

简要总结

Patients with severe respiratory diseases such as chronic obstructive pulmonary disease (COPD) or obesity-hypoventilation syndrome (OHS) can benefit from having non-invasive ventilation (NIV). NIV consists of a machine (ventilator) that is blowing air inside a patient's airway through a mask. NIV provides patients with a bigger breath. Bigger breaths help patients to have a more oxygen and less waste gas (or carbon dioxide) in their body.

These changes can improve outcomes and quality of life. In order to provide appropriate ventilation for each patient, the ventilator can generate different types of blowing:

  • Continuous positive airway pressure (CPAP) which delivers a constant flow of air through the mask
  • Pressure support ventilation (PSV) which delivers a constant flow of air through the mask and, on top of that, delivers more flow when the patient begins to inhale
  • Volume targeted ventilation which delivers a flow of air through the mask that is adjusted breath by breath in order to achieve a preset volume.

These different type of blowing have consequences on patient comfort as well as on the improvement of their ventilation.

To assess the improvement of the ventilation, currently blood tests are used, however, these reflect overall output and may miss more subtle changes in breathing that could affect how patients feel.

Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of sensors around the chest that provides information on how well the lungs are being filled with air by the ventilator. It allows a non-invasive assessment of the effect of NIV on lung ventilation in real-time.

The investigators hope to use the EIT technology to assess in real-time patients lung ventilation when they are using the NIV. The investigators hope that EIT will provide information on which type of blowing is more effective and more comfortable than the others.

详细描述

Chronic lung disease can sometimes progress to the extent that patients can no longer clear the waste gas from their blood. Treatment can be offered with a mask and machine (ventilator) that helps people breathe and aims to improve their lung condition. It is common for people's lungs to be affected variably, i.e. left more than right or top of lung more than bases of lungs. The way in which the ventilator is set may affect how well the machine deals with these differences. If the lung is better ventilator patients may find the machine more comfortable and it may be more effective.

Electrical impedance tomography (EIT) is a new technology that involves wearing a belt of sensors around the chest that provides information on how well the lungs are being filled with air by the ventilator. It allows the assessment of these differences, which previously required the use of invasive equipment to obtain.

Optimising ventilator settings in the administration of non-invasive ventilation (NIV) can be improved with the addition of individual physiological data. This approach is limited due to the invasive techniques required to obtain this information, often leading to less ideal NIV settings promoting patient-ventilator asynchrony. It has been recently demonstrated by our group that all patients established on domiciliary NIV have a degree of patient-ventilator asynchrony and that the commonest type of asynchrony are triggering issues. Triggering asynchrony is promoted by mismatch between a patient's intrinsic positive end-expiratory pressure (iPEEP) and applied expiratory positive airway pressure (EPAP) with these ineffective efforts contributing to an increased work of breathing and patient discomfort. Previous strategies used to optimise patient triggering have involved the placement of oesophageal catheters in order to measure neural respiratory drive (NRD) to the diaphragm by electromyography (EMG) but again this process is invasive and often poorly tolerated. Electrical Impedance Tomography (EIT) is a non-invasive, bedside monitoring technique that provides semi-continuous, real-time information about the regional distribution of the changes in electrical resistivity of the lung tissue due to variations in ventilation in relation to a reference state.

Information is gained by repeatedly injecting small alternating electric currents (usually 5 mA) at high frequency of 50 - 80 kHz through a system of skin electrodes (usually 16) applied circumferentially around the thorax in a single plane between the 4th and 6th intercostal space. While an adjacent pair of electrodes 'injects' the current ('adjacent drive configuration'), all the remaining adjacent passive electrode pairs measure the differences in electric potential. A resistivity (impedance) image is reconstructed from this data by a mathematical algorithm using a two dimensional model and a simplified shape to represent the thoracic cross-section.

The resulting image possesses a high temporal and functional resolution making it possible to monitor dynamic physiological phenomena (e.g. delay in regional inflation or recruitment) on a breath by breath basis. It is important to realize that the EIT images are based on image reconstruction techniques that require at least one measurement on a well-defined reference state. All quantitative data are related to this reference and can only indirectly quantify (relative) changes in local lung impedance (but not absolute).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • On domiciliary NIV for at least 3 months
  • Domiciliary NIV set up following an arterial puncture showing a PaCO2 > 6 kPa
  • Compliance of > 4 hours per night
  • FEV1 / FVC < 70% and FEV1 < 70% for COPD participants
  • FEV1 > 70% for OHS participants
  • Previous chest computed tomography for COPD participants
  • BMI >35 kg/m2 for OHS participants

排除标准

  • Pregnancy
  • Aged <18, >80
  • Significant physical or psychiatric comorbidity that would prevent compliance with trial protocol
  • Decompensated respiratory failure (pH < 7.35)
  • BMI > 50kg/m2

结局指标

主要结局

Characteristics seen during ventilation in different modes of ventilation

时间窗: 1 day

What happens to the lung when ventilation on different modes

次要结局

  • Lung volumes on EIT compared with pneumotachography assessed lung volumes(1 day)
  • Patient ventilator asynchrony(1 day)
  • Neural respiratory drive (EMGpara)(1 day)
  • Subjective patient comfort (Visual analogue scale - VAS - Borg scale)(1 day)
  • Patient comfort and lung homogeneity(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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