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临床试验/NCT02613832
NCT02613832已完成不适用

Immediate Effect of Expiratory Positive Airway Pressure and Breath Stacking in Non-cooperative Patients Detected by Electrical Impedance Tomography

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Regional Lung Aeration

研究概览

简要总结

The survival of patients with lesions in the central nervous system is usually accompanied by physical and mental sequelae. These impairments favor the prolonged restriction to the bed, which may contribute with changes in respiratory function. In this context, lung re-expansion techniques are used to prevent or treat the various respiratory complications.

详细描述

The survival of patients with lesions in the Central Nervous System is usually accompanied by physical and mental permanents sequelae. This impairment of cognitive status associated with motor injury favors prolonged restriction of these patients to the bed, which may contribute to the emergence of other health damages. In the clinical practice, lung expansion techniques has been used as a prophylaxis and treatment of respiratory conditions that involve volumetric reductions. However, the deficit of awareness and cooperation difficult the use of several therapeutic resources. There are few interventions that could be proposed due to no need the collaboration to be performed, such as Breath Stacking technique (BS) and Expiratory Positive Airway Pressure (EPAP). The BS is characterized by execution of inspiratory cycles through a one way valve, which allows stacked volume of gas during each inspiration, until it reaches values approximate to maximum inspiratory capacity. While in the EPAP, alveolar pressure is elevated to breath against a expiratory flow resistance generated by a spring load valve. The effects on lung volume promoted BS and EPAP can be safely measured using an electrical impedance tomography (EIT). This recent imaging modality offers information about lung air volumes distribution and have a strong linear correlation with regional ventilation within the thorax. The effects on lung volume promoted BS and EPAP can be safely measured using an EIT monitor. This recent imaging modality offers information about lung air volumes distribution and have a strong linear correlation with regional ventilation within the thorax. Until this moment, there is not description about the effect of lung expansion techniques on regional lung parameters.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients undergoing neurosurgery restricted to bed for more than 14 days;
  • •Aged between 18 and 65 years;
  • •Glasgow Coma Scale < 10 points;
  • •Breathing spontaneously through the tracheostomy tube;
  • •No respiratory infection;
  • •Chest circumference between 88 and 98 centimeters;

排除标准

  • •Presence of chronic lung diseases;
  • •Chest deformity;
  • •Rib fracture;
  • •Asymmetrical chest expansion;
  • •Abdomen distension;
  • •Spasticity in any hemisphere with Ashworth Scale score more than 2 points for upper limbs;
  • •Uncoordinated movements of the limbs;
  • •Cardiorespiratory instability (heart rate < 60 or > 120 bpm; respiratory rate > 35 ipm; mean arterial pressure < 60 mmHg or > 120 mmHg; oxygen saturation < 90%).

研究组 & 干预措施

EPAP Group

Experimental

The EPAP devices increase the alveolar pressure. This effect is obtained through valves that generate a resistance to airflow during expiration.

干预措施: EPAP (Other)

Breath Stacking Group

Experimental

The Breath Stacking consists on the implementation of subsequent inspiratory efforts through a one way valve, which allows stacked volume of gas during each inspiration, until it reaches a maximum lung volume.

干预措施: Breath Stacking (Other)

结局指标

主要结局

Regional Lung Aeration

时间窗: Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.

Change in Regional Lung Aeration (difference between the End-Expiratory Lung Impedance before and post-intervention). Each image along the time represent the relative change in impedance distribution within the transverse section of the chest, from the first scan (before intervention) to current scan. The pixel values are express as percentage changes of local impedance.

次要结局

  • Mean Arterial Pressure(Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.)
  • Respiratory Rate(Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.)
  • Heart Rate(Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.)
  • Periferic Saturation of Oxygen(Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.)
  • Regional Lung Ventilation(Before and 1, 5, 10, 15, 30, 60, 90, 120 minutes post-intervention.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Caio César Araújo Morais

Specialist in cardiopulmonary physiotherapy

Universidade Federal de Pernambuco

研究点 (1)

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