Identification And Prevention Of Risk Related Assistance During Stabilization Operations And Resuscitation In Newborns At Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Identify number and types of adverse events
研究概览
简要总结
Approximately 10% of term infants and up to 50% of preterm infants less than 32 weeks require stabilization and / or ventilatory support at the time of transition at birth. Coordination between the rescuer team as well as the precise knowledge of protocol resuscitation maneuvers and indications, the communication of the various professionals involved (gynecologists, pediatricians and anesthesiologists) are critical for proper care and patient stabilization. Common adverse events may hinder or impair the effectiveness of these maneuvers, ventilation, monitoring, ... with consequent worsening in the prognosis of the newborn.
详细描述
Patient safety is defined as reducing the risk of unnecessary harm associated with healthcare to an acceptable minimum, it is a task for all those involved in the care activity professionals, patients and managers. Since the incidents and adverse events involve a deficit in the quality of care causing damage to users and professionals, and increase healthcare costs, strategies should be to include both the detection and analysis of primary and secondary prevention.
The video recording programs are considered useful to monitor and detect problems during resuscitation and is believed to be useful for improving resuscitation.
HYPOTHESIS Principal: The mismatch in compliance with the guidelines for neonatal resuscitation is the main type of incident during resuscitation due to inadequate stabilization times . The cause of these incidents during resuscitation is varied and not only focuses on personal failure.
As a second hypothesis is that: the implementation of a protocol , after analysis of errors, minimizes by more than 15 % possible incidents and reduces the trip times.
EVALUATION Data collection will be made prospectively. Management during stabilization of the newborn in the delivery room with video is recorded by an independent contributor or fixed camera. Physiological parameters such as air pressure, gas flow , tidal volume , heart rate and oxygen saturation are monitored and recorded in the software monitor respiratory function and analog data FiO2
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 1 Minute（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the newborns, who require stabilization at birth in delivery room
排除标准
- •reanimation unrecorded with video
- •no obtained informed consent
结局指标
主要结局
Identify number and types of adverse events
时间窗: through study completion, an average of 1 year
Improve safety and thus the quality of health care in the stabilization and resuscitation of the newborn in Delivery Room by identifying and preventing risks related to patient care.
次要结局
- Number of income in Neonatal Unit after resuscitation(through study completion, an average of 1 year)
- Preventive measures to limit incidents(through study completion, an average of 1 year)
- Advanced reanimations(through study completion, an average of 1 year)
研究者
Manuel Sanchez Luna
Dr.
Hospital General Universitario Gregorio Marañon