Flow-cycled Ventilation in Preterm Infants (FLIPI): A Pilot Study Looking at the Tolerance of Flow-cycled Ventilation by Preterm Infants With Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Inspiratory time
研究概览
简要总结
This short pilot study is to assess the tolerance of preterm infants, born below 32 weeks gestation with respiratory distress syndrome, to flow-cycle ventilation, and see if infants require less overall pressure from the ventilator than the usual conventional settings used, with the aim of providing data to construct a larger trial looking at the longer term outcome of these infants using this type of ventilation in the future.
Many preterm infants at these gestations require assistance from a ventilator due to the immaturity of their lungs. The lungs of preterm infants are susceptible to damage, especially if high pressures are needed or prolonged periods of ventilation. There is concern that if the infant's breathing pattern does not synchronise with the ventilator, this causes additional distress, longer duration of ventilation needed and increased risk of complications. Over the past 20 years, a different type of ventilation, known as flow-cycle ventilation, has been trialed, with limited use in preterm infants. This allows the baby to determine the duration of breathing in and out and how many breaths they require per minute. This would help babies to synchronise better with the ventilator, and consequently require less pressure from the ventilator.
This pilot study is being conducted at St. Mary's Hospital, Manchester. All babies born under 32 weeks gestation, with a stable respiratory effort, will be eligible for consideration for the study. The study will last no longer than 5 hours and involve the babies receiving different pressures from the ventilator in flow-cycle mode for 1-hour epochs. Blood gases after each epoch and continuous ventilator data will be downloaded to assess their tolerance on the different settings, before being returned to the usual conventional settings used on the unit. The babies will have continuous monitoring throughout as per standard neonatal intensive care.
详细描述
This study will be conducted as a short term, crossover study, where each infant will act as his or her own control and undertake all interventions within this study. The study is broken down into two parts in order to answer the two secondary research questions.
The limited studies looking at flow-cycled ventilation in preterm babies have been set up in a similar manner. Making each infant its own control limits the number of infants needed for this pilot study.
- Prior preparations regarding protocol design
The protocol has already been reviewed by the University of Leeds, by paper submission and viva to determine the suitability of the project from an educational point of view and suitability for the restricted time frame and resources available. Discussions with the neonatal unit technical support staff have already been undertaken to ensure that the study ventilators (an exact model to that used on the unit, but mobile) are configured with the required backup ventilation mode, to maintain the required level of breathing support, safety alarms and settings checked and the Eview box (device which allows the collection of data about the baby from the ventilator) installed as per manufacture guidelines.
Training has also been given to the Principal investigator on the setup and maintenance of the study ventilator (the principal investigator is also a member of the clinical team who uses these ventilators on a daily basis and aware of how they are used). 2. Prior clinical care given & assessment for eligibility
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Hours 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under 32 weeks gestation at time of study enrolment
- •Evidence of Respiratory Distress Syndrome (Clinical signs of respiratory distress, need for surfactant / ventilation, any O2 requirement with typical Chest radiograph appearance)
- •Patients to have received loading dose of caffeine, as per unit policy
- •Informed parental consent given
- •Intubated and requiring continuing ventilatory support
- •Exogenous surfactant given if indicated (6 hours or more before study entry)
- •Cardiovascular status stable for at least 3 hours before study
- •Stable on ventilation with satisfactory blood gases & inspired oxygen concentration < 40% at time of starting study, and for the preceding 3 hours
- •Regular spontaneous respiratory effort, consistently triggering the ventilator in SIMV mode, for at least 3 hours prior to the start of the study
- •Less than 24 hours of age at the start of the study
排除标准
- •Refusal or withdrawal of parental consent
- •Major congenital abnormality, including any need for surgery
- •Known large intracranial haemorrhage (grade 3 or 4 intraventricular haemorrhage or other significant intracranial abnormality)
- •Pneumothorax or pulmonary interstitial emphysema
- •Inspired oxygen requirement > 40% after surfactant administration
研究组 & 干预措施
Preterm infants with RDS
干预措施: Flow-cycle ventilation (Other)
Preterm infants with RDS
干预措施: Time-cycle ventilation mode (Other)
结局指标
主要结局
Inspiratory time
时间窗: 6 hours
Amount of time the infant require inspiratory support from the ventilator (in flow-cycle mode only)
Mean airway pressure used
时间窗: 6 hours
Amount of pressure required in either ventilation mode
Respiratory rate
时间窗: 6 hours
Spontaneous respiratory rate from infant in either ventilation mode
次要结局
- Exhaled tidal volume(6 hours)
- Exhaled minute ventilation(6 hours)
- Oxygen requirement(6 hours)
- Acid - base balance(In each 1-hour epoch (end of))