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临床试验/NCT05399914
NCT05399914Unknown不适用

Feasibility and Reliability of Synchronized Non-invasive Intermittent Positive Pressure Ventilation in Preterm Infants After Birth

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年4月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Synchronisation rate

研究概览

简要总结

The aim of this prospective observational study (pilot study) is to test if synchronized noninvasive positive pressure ventilation (S-NIPPV) is feasible and works appropriately during transition from intrauterine to extrauterine life in very preterm infants in the delivery room.

详细描述

The study period will be the first 10 minutes after birth.

All patients will be non-invasively ventilated using an EVE NEO ventilator (CE 0482, Fritz Stephan GmbH, Gackenbach, Germany). A facemask will be used throughout the study period. Synchronization will be achieved using graseby capsule (Stephan, Vio Healthcare), which will be secured at the abdominal wall on the midaxillary line below the ribs. For the detection of spontaneous breaths respiratory induction plethysmography (RIP) is used. For this purpose, an extra small plethysmography belt (Sleepsense, Elgin, USA) is placed around the abdomen. The data of the plethysmography belts are processed and stored with the NewLifebox-XL (Advanced Life Diagnostics UG, Weener, Germany) and merged with the data from the ventilator for later evaluation.

Infants according to the clinician's assessment only needing CPAP will receive S-NIPPV with very low PIP levels. This enables to have enough ventilator breaths applied for analysis to obtain sufficient data about the synchronization rate of S-NIPPV in the delivery room and meanwhile consider the infant's safety by not applying high pressures where it might not be needed. The ventilator support settings will be PIP 10, PEEP 6 in the noninvasive pressure controlled assist control ventilation (nPC-ACV+) mode. In this mode every spontaneous breath is supported by a ventilator breath (if the triggering level is exceeded). The triggering level will be set at 0,5 to avoid autotriggering and unsupported breaths. The inspiratory time will be set at max. 0,3 sec. The backup ventilation rate is set at 60 per minute.The EVE NEO ventilator has in the nPC-ACV+ mode an option where the ventilator breaths are interrupted/stopped as soon as the graseby capsule detects a start of spontaneous expiration.

If the infant according to the clinician's assessment needs S-NIPPV (e.g. the infant is apnoeic, and/or heart rate is below 100 bpm), the pressure of S-NIPPV will be augmented to target PIP 20, PEEP 6 (unless clinical concerns require an adjustment). The respiratory support can be deescalated to PIP 10 once the clinician deems the higher pressure no longer necessary.

The following demographical characteristics will be collected from the patient charts (pseudonymized): gender, gestational age, birth weight, antenatal steroids, mode of delivery, reason for prematurity (prolong premature rupture of membrane, infection, pathologic CTG, pathological doppler, gestosis), time of cord clamping, umbilical cord pH, FiO2 requirement, APGAR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Preterm infants with a gestational age (GA) between 26 ≥ and < 32 weeks

排除标准

  • Major congenital malformations
  • Refused parental consent (prenatal parental consent is necessary)

结局指标

主要结局

Synchronisation rate

时间窗: First 10 minutes after birth

Synchronisation rate (sensitivity/true positive rate) of S-NIPPV in the delivery room meaning the proportion of graseby triggered synchronized ventilator breaths with corresponding RIP signal related to all spontaneous breaths detected by RIP.

次要结局

  • Positive end expiatory pressure (PEEP)(First 10 minutes after birth)
  • Proportion of time non invasive ventilator breaths will be applied.(First 10 minutes after birth)
  • False negative rate(First 10 minutes after birth)
  • Mean airway pressure (MAP)(First 10 minutes after birth)
  • False positive rate(First 10 minutes after birth)
  • Specificity (true negative rate)(First 10 minutes after birth)
  • Proportion of back up breaths(First 10 minutes after birth)
  • Peak inspiratory pressure (PIP)(First 10 minutes after birth)
  • Td (time delay) graseby(First 10 minutes after birth)
  • Ti ventilator(First 10 minutes after birth)
  • Ti RIP(First 10 minutes after birth)
  • Fraction of inspired oxygen(First 10 minutes after birth)
  • Proportion of artifacts(First 10 minutes after birth)
  • Proportion of time of synchronised breaths, non-synchronized breaths, periods of apnoea and periods of movement artefacts occure within the first ten minutes of respiratory support.(First 10 minutes after birth)
  • Time until the graseby capsule is attached to the infant's abdomen and the proportion of infants in whom the graseby capsule is attached within the first two minutes after birth.(First 10 minutes after birth)
  • Td (time delay) ventilator(First 10 minutes after birth)
  • Swing RIP(First 10 minutes after birth)
  • Number of tactile stimulations and other interventions on the patient(First 10 minutes after birth)
  • Oxygen saturation(First 10 minutes after birth)
  • Ti excess(First 10 minutes after birth)
  • Heart rate(First 10 minutes after birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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