Randomized Control Trial of Colorimetric CO2 Detectors for Ventilation Assessment in the Delivery Room
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 632
- 试验地点
- 1
- 主要终点
- Duration of positive pressure ventilation (PPV)
研究概览
简要总结
The goal of this study is to determine if using a Pedi-Cap (a type of colorimetric carbon dioxide detector) during face mask ventilation (PPV) for newborn infants in the delivery room will lower the time of PPV needed. A group of nurses, doctors, and respiratory therapists, called the neonatal resuscitation team, will either use or not use the Pedi-Cap during face mask PPV for infants born at ≥30 weeks' gestation.
A randomization generator will assign each month to either use the Pedi-Cap or not use the Pedi-Cap. The researchers will collect information from the medical chart to find the infant and mother's information, medical interventions done in the delivery room, and lab values. In addition, resuscitation team members will fill out a survey of their experiences of using or not using the Pedi-Cap during delivery room facemask PPV.
详细描述
This is an open, prospective, quasi-randomized, single center trial that will address the primary research question: Does use of a colorimetric carbon dioxide (CO2) detector (Pedi-Cap) decrease the duration of non-invasive positive pressure ventilation (PPV) in the delivery room? The neonatal resuscitation team, comprised of nurses, doctors, and respiratory therapists will include or omit the Pedi-Cap during noninvasive PPV for infants born at ≥30 weeks' gestation in the delivery room. The quasi-randomization scheme will be determined by a opening an opaque envelope each month. This will be revealed at the beginning of each month on whether to use the Pedi-Cap or not. Other outcomes variables that will be assessed include initial heart rate (HR), time to HR > 100 bpm, duration of bradycardia, time to start of ventilation corrective maneuvers (if needed), maximum peak inspiratory pressure used, maximum peek inspiratory pressure used, maximum fractionated inspired oxygen, time to gold color change on Pedi-Cap, need for intubation, need for delayed PPV, need for chest compressions/epinephrine, need for neonatal intensive care unit admission if infant ≥35 gestational age, occurrence of pneumothorax, length of mechanical ventilation in days, doses of surfactant given, and survival to discharge. Infant and maternal characteristics will be obtained from the electronic medical record. Association of outcomes with each study arm will be stratified by infant and maternal characteristics.
In addition, a survey will be administered to the resuscitation team members at the completion of the study to assess their experience with each study arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at ≥30 weeks' gestation
- •Presence of the resuscitation team prior to delivery
- •Need for non-invasive positive pressure ventilation (PPV).
排除标准
- •Infants born at <30 weeks' gestation
- •No non-invasive PPV needed in the delivery room
- •Infants with conditions requiring immediate intubation such as congenital diaphragmatic hernia
- •Resuscitation team not present prior to delivery/need for PPV
- •Infants who have a prenatal plan of comfort care only
研究组 & 干预措施
Pedi-Cap
A Pedi-Cap will be connected to the T-piece resuscitator in between the T-piece and face mask. With effective gas exchange, carbon dioxide (CO2) is detected by the Pedi-cap and will demonstrate gold color change with each exhalation. If there is no CO2 gas exchanged, the Pedi-Cap color will remain purple. The color change will be used as one of the tools for the resuscitation team to determine if the infant has effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation. Other ways, in addition to the Pedi-Cap, to determine effective PPV include a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation.
干预措施: Pedi-Cap (Device)
No Pedi-Cap
There will be no Pedi-Cap attached to the t-piece resuscitator. Effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation will be assessed by a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation.
结局指标
主要结局
Duration of positive pressure ventilation (PPV)
时间窗: From birth to end of delivery room resuscitation or admission to the Neonatal Intensive Care Unit (NICU) (approximately 1 hour of life)
The time that an infant needs non-invasive PPV during delivery room resuscitation.
次要结局
- Duration of bradycardia(From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life))
- Time to heart rate great than 100 beats per minute(From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life))
- time to start of ventilatory corrective maneuvers(From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life))
- Maximum peak inspiratory pressure used(From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life))
- Time to gold color change on Pedi-Cap(From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life))
- Need for intubation in the delivery room(From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life))
- need for delayed positive pressure ventilation(From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life))
- Need for chest compressions or epinephrine(From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life))
- Need for neonatal intensive care unit admission if infant ≥35 gestational age(From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life))
- Occurrence of pneumothorax(From birth to 3 days of life)
- Duration of mechanical ventilation(From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks)
- Need for surfactant(From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks)
- Maximum positive end expiratory pressure used(From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life))
- Maximum fractionated inspired oxygen used(From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life))
- Survival to discharge(birth to discharge from NICU (up to 12 months of age))
研究者
Riti Chokshi, MD
Principal Investigator
University of Texas Southwestern Medical Center