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临床试验/NCT05036603
NCT05036603已完成不适用

Comparison of the Acute Effects of Chest Physiotherapy Methods Applied in Different Positions in Preterm Newborns

Sanko University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4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
60
试验地点
2
主要终点
blood pressure

研究概览

简要总结

Infants in the neonatal intensive care unit (NICU) may be lost due to risks such as being sensitive, frequent exposure to birth complications and being prone to infection. The most common causes of mortality in newborn babies in the world; Complications due to preterm delivery (28%), infections (26%) and perinatal asphyxia (23%) were reported. Respiratory problems are observed in 4-6% of newborns. These problems are also important causes of mortality in the neonatal period. Newborn infants are more likely to have respiratory distress due to difficulties in airway calibration, few collateral airways, flexible chest wall, poor airway stability, and low functional residual capacity.Invasive mechanical ventilation (IMV) is frequently used in the treatment of newborns with respiratory failure. Various ventilation modes and strategies are used to optimize mechanical ventilation and prevent ventilator-induced lung injury. Among the important issues to be considered in newborns connected to mechanical ventilator (MV); Choosing an appropriately sized endotracheal tube to reduce airway resistance and minimize respiratory workload, correct positioning, regular nursing care, chest physiotherapy, sedation-analgesia, and infection prevention are also included.

详细描述

Infants in the neonatal intensive care unit (NICU) may be lost due to risks such as being sensitive, frequent exposure to birth complications and being prone to infection. The most common causes of mortality in newborn babies in the world; Complications due to preterm delivery (28%), infections (26%) and perinatal asphyxia (23%) were reported. Respiratory problems are observed in 4-6% of newborns. These problems are also important causes of mortality in the neonatal period. Newborn infants are more likely to have respiratory distress due to difficulties in airway calibration, few collateral airways, flexible chest wall, poor airway stability, and low functional residual capacity.Invasive mechanical ventilation (IMV) is frequently used in the treatment of newborns with respiratory failure. Various ventilation modes and strategies are used to optimize mechanical ventilation and prevent ventilator-induced lung injury. Among the important issues to be considered in newborns connected to mechanical ventilator (MV); Choosing an appropriately sized endotracheal tube to reduce airway resistance and minimize respiratory workload, correct positioning, regular nursing care, chest physiotherapy, sedation-analgesia, and infection prevention are also included.The preference for using non-invasive mechanical ventilation (NIMV) modes in NICUs is also increasing. Despite this, the use of IMV is still often required in preterm infants in the need for respiratory support and in the treatment of respiratory failure. Today, extremely preterm infants are extubated quickly. Because prolonged IMV can be a very important risk factor in the development of Bronchopulmonary Dysplasia (BPD). The reason for this is the physiological characteristics of newborns such as airway maintenance and cleanliness, smaller airway calibration, reduction in collaterals, flexible chest wall, poor airway stability, and low functional residual capacity. A small amount of secretion in preterm infants can produce a large increase in airway resistance. This reduces airflow and without expiratory flow, secretions cannot be expelled. With chest physiotherapy (CP), adequate expiratory flow can be achieved without causing airway closure.Chest physiotherapy techniques (CP) create mechanical effects in the lung, increasing ventilation, facilitating the removal of secretions and preventing bronchial obstruction. This ensures correct protection of the airways and facilitates extubation. Prolonged intubation and increased length of stay in NICUs can also lead to complications such as atelectasis, respiratory infections and chronic lung disease. Decreased oxygenation and excessive accumulation of secretions cause widespread increase in airway resistance, leading to prolonged ventilation or oxygen support. Oxygen therapy is an integral part that is frequently used as respiratory support in NICUs. However, long-term oxygen therapy may cause excessive accumulation of bronchial secretions. This makes CP mandatory. Traditional CP has become an indispensable part of airway management in NICU settings to remove excess bronchial secretions and thereby increase oxygenation. There are many studies on CP in the literature.In some of these studies, it was found that it did not prevent atelectasis, that CP had no effect, or that CP accelerated weaning from MV. The role of CP in reducing respiratory morbidity in infants and neonates continues to be debated and more studies are needed. CP needs to be supported by well-controlled studies with large sample sizes, particularly regarding the techniques used and specific protocols. Therefore, in this study, it is aimed to compare the acute effects of CP methods applied in different positions in preterm newborns.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 45 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm newborns born <37 and >28 weeks due to MV or CPAP, hospitalized in the NICU and with a voluntary consent form from their families (with segmental lobar collapse as a result of Chest X-Ray, RDS/BPD/HMH/Atelectasis/Pneumonia/ Preterm newborns diagnosed with Chronic Pulmonary Disease or in stable condition with a thick and secretory focus on X-ray)
  • First-time infants who have not received any chest physiotherapy program

排除标准

  • Newborn infants who have been unstable in the last 2 days (SpO₂ <60 mmHg, heart rate, blood pressure, persistent apnea, excessive increases in respiratory rate, tachycardia, nasal wing breathing, cyanosis..etc)
  • Newborn infants with rib fracture, hemoptysis, diaphragmatic hernia, pulmonary hemorrhage, pneumothorax
  • Those diagnosed with any known heart disease or genetic disease
  • Those with osteopenia-osteoporosis or thrombocytopenia
  • Infants with any known neurological diagnosis (Abnormal MRI finding, Hydrocephalus, Chiari Malformation, Asphyxia, Periventricular Leukomolacia (PVL), Intraventricular Hemorrhage (IVH), Kernicterius, Hypoxic Ischemic Encephalopathy (HIE), Hydrocephalus)
  • Preterm infants weighing <1000 g
  • Infants born with congenital anomaly (Spina Bifida, Arthrogryposis Multiplex Congenita..etc)
  • Newborns undergoing any surgery

结局指标

主要结局

blood pressure

时间窗: on the time before starting chest physiotherapy and up to15 minutes after ending therapy

blood pressure of the preterm newborns

chest X-Ray

时间窗: on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session

chest X-Ray of the preterm newborns

heart rate

时间窗: Before starting chest physiotherapy and up to15 minutes after ending therapy

heart rate of the preterm newborns

arterial blood gases

时间窗: on the 1st day before starting chest physiotherapy session and up to 24 hours after chest physiotherapy session

arterial blood gases from the radial artery or from the umbilical catheter in infants with an umbilical catheter

respiratory rate

时间窗: Before starting chest physiotherapy and up to15 minutes after ending therapy

respiratory rate of the preterm newborns

Peep (cm H₂O)

时间窗: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy

Peep (cm H₂O) of the preterm newborns

FİO₂ (%/mm Hg)

时间窗: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy

FİO₂ (%/mm Hg) of the preterm newborns

Pip (cm H₂O)

时间窗: on the time before starting chest physiotherapy and up to15 minutes after ending therapy

Pip (cm H₂O) of the preterm newborns

PaO₂

时间窗: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy

PaO₂ of the preterm newborns

O₂ Saturation (mmHg) (SpO₂)

时间窗: on the time before starting chest physiotherapy and up to 15 minutes after ending therapy

O₂ Saturation (mmHg) (SpO₂) of the preterm newborns

次要结局

  • Chest shape and type (barrel/pektusexcavatum..etc)(on the time before starting chest physiotherapy and up to 15 minutes after ending therapy)
  • Daily nutrition type(on the time before starting chest physiotherapy and up to 24 hours after chest physiotherapy)
  • the respiratory pattern(on the time before starting chest physiotherapy and up to 15 minutes after ending therapy)
  • Respiratory stress(before physiotherapy)

研究者

发起方
Sanko University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hatice Adiguzel, PT

Assistant Proffessor

Sanko University

研究点 (2)

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