Comparative Study of the Effects of Continuous Positive Airway Pressure and Heated, Humidified High Flow Nasal Cannula on Diaphragmatic Dimensions in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)
研究概览
简要总结
This is a prospective, randomized crossover study to recognize the effects of nasal continuous positive airway pressure (CPAP) versus heated humidified high flow nasal cannula (HHHFNC) on diaphragmatic dimensions and excursion (evaluated by ultrasonography) in preterm infants.
详细描述
Preterm infants will be recruited consecutively from NICU of Mansoura University Children's Hospital. They will be randomized in two groups; one group will start on nasal CPAP (Fisher & Paykel Healthcare, Auckland, New Z ealand) (Pressure 5 cmH2O) for 60 minutes and then will be switched to HHHFNC (Fisher & Paykel Healthcare, Auckland, New Z ealand) (flow of 4 l/m) for another 60 minutes. The other group will start on HHHFNC and then switched to nasal CPAP.
After the 2 h study period (2×60 minutes epochs) further respiratory support will be at the discretion of the clinical team.
Ultrasonographic assessment of diaphragmatic dimensions and excursion will be analyzed in different respiratory cycles and the average of 3 cycles will be calculated at the end of the 60 minutes periods on nasal CPAP and HHHFNC.
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
- None
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants < 37 weeks.
- •Stable on nasal continuous positive airway pressure (CPAP) for at least 24 hours.
- •On less than 35% oxygen.
排除标准
- •Congenital and acquired problems of the gastrointestinal tract as necrotizing enterocolitis, esophageal perforation and tracheoesophageal fistula.
- •Phrenic nerve injury and/or diaphragm paralysis
- •Congenital/acquired neurological deficit and/or seizures
- •Hemodynamic instability
- •Congenital heart disease (including symptomatic patent ductus arteriosus)
- •Undergoing treatment for sepsis or pneumonia.
- •Use of muscle relaxants, narcotic analgesics, or gastric motility agents.
- •Congenital anomalies of respiratory tract.
- •Infants requiring more than 35% oxygen.
- •Infants with facial anomalies.
- •Infants with pneumothorax and/or pneumomediatinum.
- •Infants in the immediate postoperative period.
- •Infants with significant gastric residues and vomiting.
结局指标
主要结局
Diaphragmatic dimensions (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness)
时间窗: at the end of each 60 minutes epochs on HHHNC
Ultrasonographic assessment of (inspiratory diaphragmatic thickness, expiratory diaphragmatic thickness and delta diaphragmatic thickness will be assessed at the end of each 60 minutes epoch on HHHFNC. Diaphragm thickness will be measured as the perpendicular distance between the pleural and peritoneal reflections. All measurements will be performed during quiet breathing. Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
Right and left diaphragmatic excursion
时间窗: at the end of each 60 minutes epochs on HHHNC
Ultrasonographic assessment of right and left diaphragmatic excursion will be assessed at the end of each 60 minutes epoch on HHHFNC. The displacements of the liver and spleen will be monitored in real-time. Using M-mode ultrasonography, with the probe fixed on the chest wall during respiration, ultrasonographic image of will be frozen and a mark for measurement will be placed on the image at the location of the most caudal margin of the liver or spleen at the end of expiration, and a second mark will be placed on the new location of the most caudal margin of the liver or spleen at the end of inspiration. The distance between the two marks will be then measured and defined as the displacement of the liver or the spleen (right or left diaphragmatic excursion). Several respiratory cycles will be recorded, and measurements will be averaged from at least three different cycles.
次要结局
- Respiratory rate(At the end of each 60 minutes epochs on CPAP and HHHFNC)
- Heart rate(At the end of each 60 minutes epochs on CPAP and HHHFNC)
- Spo2(At the end of each 60 minutes epochs on CPAP and HHHFNC)
- Number of apneas(during the 60 minutes epochs on CPAP and HHHFNC)
研究者
Hesham Abdel-Hady
Professor of Pediatrics
Mansoura University Children Hospital