跳至主要内容
临床试验/NCT03768921
NCT03768921已完成不适用

Use of Electrical Impedance Tomography in Children With Syndrome of Acute Respiratory Disorder

Universidade Metodista de Piracicaba2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Alveolar hiperdistension

研究概览

简要总结

INTRODUCTION: Electrical impedance tomography is a tool for noninvasive monitoring of pulmonary ventilation in real time, which is used during alveolar recruitment maneuvers in patients with acute respiratory distress syndrome. OBJECTIVES: To identify ventilatory and hemodynamic changes during the alveolar recruitment maneuver in children with acute respiratory distress syndrome using electrical impedance tomography. METHODS: Twenty children, aged 4 to 12 years, who present a diagnosis of respiratory distress syndrome, with indication of alveolar recruitment admitted to the Pediatric Intensive Care Unit of the Santa Casa de Misericórdia Foundation of Pará will be selected. Data collection will consist of three before the alveolar recruitment maneuver, immediately after the alveolar recruitment maneuver, 2 hours after the alveolar recruitment maneuver, where the pulmonary ventilation distribution, the driving pressure, the real-time reading compliance will be analyzed. tomography of the Timpel brand, autonomic heart rate modulation through the Polar® RS800CX device, physiological variables such as heart rate, oxygen pulse saturation and blood pressure by measuring the DIXTAL multi-parameter monitor, blood oxygen pressure and the oxygen content dog. The statistical analysis will be performed in the Biostat 5.2 program, and the choice of tests will depend on the types of distributions found and the homogeneity of the respective variances.

详细描述

The present study will be developed at the referral hospital in the north of the country, Santa Casa de Misericórdia Foundation of Pará, located at Rua Bernal do Couto 992, Bairro Umarizal, Belém (PA), Unit of Intensive Pediatric Therapy, with the participation of the unit's interdisciplinary team. The data collection period will take place between December 2017 and February 2019.

For the measurement of ventilatory variables (static and regional compliance, regional ventilation, driving pressure, alveolar hyperdistension, alveolar collapse and PEEP titration), the Timpel® Brand Electrical Impedance Tomography monitor will be used to measure hemodynamic variables arterial and oxygen pulse saturation) a DIXTAL® brand monitor will be used.

The instruments used to measure HRV will be the Polar® RS800CX device that features WearLink heart rate sensor, elastic band, contact gel, interface with USB input and a computer.

After the selection and acceptance of the terms of consent and clarification of doubts the research will be carried out in four stages, where the first one will start before performing the alveolar recruitment maneuver; the second, during the alveolar recruitment maneuver; the third, 24 hours after the alveolar recruitment maneuver; and the fourth 48 hours after the alveolar recruitment maneuver. Each of said steps will be divided into sub-steps according to the procedures.

Before the beginning of the alveolar recruitment maneuver, the minor will be sedated and curarized, in order to avoid interference in the recruitment protocol and thus increase the incidence of complications such as increased intrathoracic pressure and consequent alveolar rupture.

研究设计

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

盲法说明

The research design is a longitudinal, quantitative and analytical clinical trial.

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of ARDS, aged 7 to 12 years;
  • Indication of treatment with alveolar recruitment maneuver.

排除标准

  • Clinical condition that does not allow alveolar recruitment maneuvers
  • Severe hypotension
  • Cardiac arrhythmia
  • Pneumothorax
  • Pneumatocele untreated.

结局指标

主要结局

Alveolar hiperdistension

时间窗: Evaluation during two days

the percentage of hyperdistended alveoli, which indicates that the alveoli are with excess air in their interior.

Driving pressure

时间窗: evaluation during two days

The driving pressure, which indicates alveolar pressure variation and alveolar distension capacity, will be evaluated.

Alveolar collapse

时间窗: evaluation during two days

the percentage of alveolar collapse, which indicates how much the pulmonary alveolus is without air.

Regional air ventilation

时间窗: Evaluation during two days

Regional air ventilation, which indicates how air is distributed in the lung, demonstrating the most ventilated and least ventilated areas in the lung.

次要结局

未报告次要终点

研究者

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

Rodrigo Santiago Barbosa Rocha, Phd

Department of Movement Human Sciences Coordinator

Universidade Metodista de Piracicaba

研究点 (2)

Loading locations...

相似试验