Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly in the Delivery Room: Multicentre Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 10
- 主要终点
- Estimation of the success rate of cardiorespiratory resuscitation in less than 90s with the Umbilical vein catheterization through Wharton's jelly as 1st line, in neonates in circulatory arrest in the delivery room
研究概览
简要总结
The aim of this study is to demonstrate, with a good level of evidence, the efficacy, safety and feasibility of placing an umbilical route through Wharton's jelly, in the context of emergency situations in the delivery room.
详细描述
In France, it is estimated that 2 to 4 births per 1000 are complicated by perinatal anoxia. This infrequent event constitutes a vital emergency because, in addition to death, the consequences, particularly neurological, are serious for the survivors. Mortality is high,and estimated at more than half of children when an Apgar score of zero is observed at 5 and 10 minutes, as shown by data found in the literature. When children are born in circulatory arrest, rapid recovery of a heart rate (HR) of more than 100 beats per minute (bpm) to allow correct circulation is therefore essential.
The recommendations of the European Resuscitation Council, updated in 2021, help to guide the birth room practitioner for optimum effectiveness. If the heart rate remains low, after the ventilation method and interface have been checked and adjusted if necessary, cardiac massage is started, and the next step is the emergency administration of adrenaline via the venous route. The reference route is currently the umbilical venous route via an umbilical venous catheter (UVC). This method is effective, but remains a technical procedure and takes a long time to set up, lasting an average of 3 minutes and up to 6 minutes, including just 1 and a half minutes to prepare the equipment and the venous approach. The intra-tracheal route is not prohibited by the latest recommendations, but it has not been shown to be effective and has not been adopted as a reference emergency route in this indication. The intraosseous route has also been studied and mentioned in the recent recommendations of the Société Française de Néonatalogie, but it remains highly invasive and is not routinely used by neonatal resuscitators or paediatricians in the delivery room. Peripheral venous access is difficult because of hypoperfusion, and is not indicated in these emergency situations either.
In this context, the investigator propose to evaluate a quicker and easier infusion method enabling adrenaline to be administered without delay to neonates in circulatory arrest, when the indication is given, i.e. after a well-conducted initial resuscitation. This method consists of catheterising the umbilical vein directly through Wharton's jelly, and injecting the treatments into it.
The aim of this study is to demonstrate, with a good level of evidence, the efficacy, safety and feasibility of placing an umbilical route through Wharton's jelly, in the context of emergency situations in the delivery room.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full-term newborn (≥ 37 SA)
- •Newborn for whom a resuscitation decision has been taken.
- •Newborn in circulatory arrest, or in profound bradycardia < 60 bpm, requiring an injection of adrenaline in the delivery room, the indication being established in accordance with the recommendations of the European Resuscitation Council 2021, after completion of the first stages of cardiopulmonary resuscitation, including the establishment of effective ventilation
- •Newborn beneficiary of a social security scheme or entitled person.
- •Non-inclusion Criteria :
- •Newborn with known heart defects or other potentially lethal defects
- •Presence of a pre-existing access route
- •Paediatric resuscitator not trained to the UVW procedure
- •Twins born in circulatory arrest and requiring simultaneous management
排除标准
- 未提供
结局指标
主要结局
Estimation of the success rate of cardiorespiratory resuscitation in less than 90s with the Umbilical vein catheterization through Wharton's jelly as 1st line, in neonates in circulatory arrest in the delivery room
时间窗: At the beginning of the study, an average of 90 seconds
Successful completion of the Umbilical vein catheterization through Wharton's jelly procedure is defined as achieving a heart rate (HR) greater than 100 bpm within 90 seconds of the start of the procedure, which corresponds to cord asepsis. The reference procedure (UVC), which has been prepared in parallel, is used as soon as it is ready, if the heart rate is not greater than 100 bpm. The Umbilical vein catheterization through Wharton's jelly procedure is then considered to have failed (because the line has not been inserted, the catheter injection has not been performed or the target rate has not been reached within the time limit)
次要结局
- Measurement of the frequency of failure of the Umbilical vein catheterization through Wharton's jelly procedure(At the beginning of the study, an average of 90 seconds)
- Measurement of the time taken to insert the umbilical line through Wharton's jelly(At the beginning of the study, an average of 90 seconds)
- Measurement of the delay between the start of the Umbilical vein catheterization through Wharton's jelly procedure and the achievement of a heart rate greater than 100 bpm, to be compared with the delay for an injection via UVC if applicable(At the beginning of the study, an average of 90 seconds)
- Measurement of the delay between the injection of adrenaline by catheter and the resumption of a heart rate greater than 100 bpm, to be compared with the line actually used(At the beginning of the study, an average of 90 seconds)
- Description of the types of procedure failure and their causes, requiring the use of another approach(At the beginning of the study, an average of 90 seconds)
- Measurement of immediate mortality (at H1) and mortality at discharge from hospital, or 28 days, overall and according to the approach actually used (Umbilical vein catheterization through Wharton's jelly procedure vs UVC)(At the beginning of the study, an average of 90 seconds)
- Measurement of tolerance and safety: adverse events within 72 hours, overall and according to the approach used (Umbilical vein catheterization through Wharton's jelly procedure vs UVC)(At 72 hours after the beginning of the study)
- Study of the relationship between the delay to inject adrenaline by catheter with the Umbilical vein catheterization through Wharton's jelly procedure and the practitioner's experience, or the condition of the cord(At the beginning of the study, an average of 90 seconds)
- Description of the difficulties encountered when using the Umbilical vein catheterization through Wharton's jelly procedure(At the beginning of the study, an average of 90 seconds)