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临床试验/NCT05474170
NCT05474170已完成不适用

Impact of 2 Resuscitation Sequences on Alveolar Ventilation During the First Minute of Simulated Pediatric Cardiac Arrest: Randomized Cross-Over Trial

Geneve TEAM Ambulances2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
2
主要终点
Median Alveolar Ventilation

研究概览

简要总结

The International Liaison Committee on Resuscitation regularly publishes a Consensus on Science with Treatment Recommendations but guidelines can nevertheless differ when knowledge gaps persist. In case of pediatric cardiac arrest, the American Heart Association recommends following the adult resuscitation sequence i.e., starting with chest compressions. Conversely, the European Resuscitation Council advocates the delivery of 5 initial rescue breaths before starting chest compressions. Carrying out a randomized trial in children in cardiac arrest to assess the impact of these strategies would prove particularly challenging and ethical concerns may prevent such a trial from being performed. This will be a superiority, cross-over randomized trial whose goal is to determine the impact of these 2 resuscitation sequences on alveolar ventilation in a pediatric model of cardiac arrest. While not definitive, its results could help fill part of the current knowledge gap.

详细描述

This will be a randomized, cross-over, superiority trial. The intention is to carry it out on the first Prehospital Research Day which will be held on September 1st, 2022, i.e., on a single date. This event will take place at a single center in Neuchâtel, Switzerland. If the intended sample size cannot be reached on this day, or if technical issues prevent data from being collected or extracted, other study sites will be considered.

Participant recruitment will be conducted online. A web-based platform based on the Joomla 4 (Open Source Matters, New York, USA) content management system will be specifically created for the purpose of this study. The Event Booking 4 component (Joomdonation, Hanoi, Vietnam) will be used to create 20-minute time slots. Demographic data will be collected during the registration process. Consent will be gathered electronically.

Since the objective of this study is to assess the impact of basic airway management and ventilation maneuvers only, there will be no stratification since all the professionals eligible for inclusion should be equally proficient in basic airway management. Furthermore, all participants will be able to practice this skill on a manikin identical to the one used to perform the study. This training will not be time limited and will take place immediately before the sequence during which data will be collected.

An investigator who will not be present during the resuscitation sequences will create stacks of opaque, sealed envelopes. Each stack of 10 envelopes will contain an equal number of American Heart Association (AHA) and European Resuscitation Council (ERC) allocations. Randomization will take place after the training session. The first leader will choose and open one of the envelopes placed on a table in random order by one of the on-site investigators. This will determine the resuscitation sequence which will first be used by the team.

A SimBaby manikin (Laerdal SimBaby, Laerdal Medical, Stavanger, Norway) will be used in this study. The SimBaby is a realistic manikin representing a 9-month-old infant. The manikin weighs 4.9 kg and is 71 cm tall. It is accompanied with a dedicated multiparameter monitor/defibrillator. Back compensation, using a folded blanket, will be applied. An appropriately sized bag-valve-mask (BVM) device will be ready for use next to the manikin. The defibrillation pads will be already attached.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Data extraction will be fully automated and the statistician will not know the identity of the participants or the sequence they were allocated to.

入排标准

性别
All
接受健康志愿者

入选标准

  • Being issued from one of the following profession: Emergency medical technicians (EMTs), paramedics, nurses and physicians

排除标准

  • Being member of the study team

研究组 & 干预措施

AHA --> ERC

Experimental

This group will first apply the AHA resuscitation sequence, then the ERC one

干预措施: AHA resuscitation sequence (Other)

AHA --> ERC

Experimental

This group will first apply the AHA resuscitation sequence, then the ERC one

干预措施: ERC resuscitation sequence (Other)

ERC --> AHA

Active Comparator

This group will first apply the ERC resuscitation sequence, then the AHA one

干预措施: AHA resuscitation sequence (Other)

ERC --> AHA

Active Comparator

This group will first apply the ERC resuscitation sequence, then the AHA one

干预措施: ERC resuscitation sequence (Other)

结局指标

主要结局

Median Alveolar Ventilation

时间窗: 1 minute

The alveolar ventilation was determined by subtracting the dead space volume from each ventilation. According to the appropriate Best Guess formula, a 9-month old infant should weigh around 9 kg (0.5 x age in months + 4.5). Using the formula proposed by Numa and Newth, this corresponds to a dead space of around 25 ml. The value reported was the median \[quartiles\] over the first minute.

Alveolar ventilation

时间窗: 1 minute

The alveolar ventilation will be determined by subtracting the dead space volume from each ventilation. According to the appropriate Best Guess formula, a 9-month old infant should weigh around 9 kg (0.5 x age in months + 4.5). Using the formula proposed by Numa and Newth, this corresponds to a dead space of around 25 ml.

次要结局

  • The Percentage of Chest Compressions Within, Above and Below the Target Rate.(1 minute)
  • The Chest Compression Fraction (CCF)(1 minute)
  • The Percentage of Compressions With Adequate Chest Recoil(1 minute)
  • The Total Number of Ventilations(1 minute)
  • The Percentage of Ventilations Within, Above and Below the Target Volume(1 minute)
  • The Alveolar Ventilation Obtained Without Taking Ventilation Volumes Over 70 ml Into Account, Reported as the Median Value of the Ventilations Over the First Minute.(1 minute)
  • The Percentage of Compressions of Correct Depth(1 minute)
  • The total number of ventilations(1 minute)
  • The proportion of ventilations within, above and below the target volume(1 minute)
  • The proportion of chest compressions within, above and below the target rate.(1 minute)
  • The chest compression fraction (CCF)(1 minute)
  • The alveolar ventilation obtained without taking ventilation volumes over 70 ml into account(1 minute)
  • The proportion of compressions of correct depth(1 minute)
  • The proportion of compressions with adequate chest recoil(1 minute)

研究者

发起方
Geneve TEAM Ambulances
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stuby Loric

Principal Investigator

Geneve TEAM Ambulances

研究点 (2)

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