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临床试验/NCT06306898
NCT06306898已完成不适用

Intra-Arrest-Ventilation - a Prospective Randomized Trial in Human Cadavers

Gerrit Jansen1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年3月18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
Gerrit Jansen
入组人数
10
试验地点
1
主要终点
Ventilation Pressure with different Airway devices in CCSV

研究概览

简要总结

The study investigates the influence of non-synchronized bag-device-ventilation and intermittent positive pressure ventilation (IPPV), as recommended in the current resuscitation guidelines of the European Resuscitation Concil (tidal Volume (Vt) = 5-6 mL/kg body weight, respiratory rate = 10 min-1) and Chest Compression Synchronized Ventilation (pInsp = 40 mbar; respiratory rate = chest compression rate) with regard to achieving a sufficient tidal volume and the tightness of various supraglottic airway devices (laryngeal mask, i-Gel-laryngeal mask, laryngeal tube) and endotracheal intubation.

详细描述

The European Resuscitation Council (ERC) guidelines for cardiopulmonary resuscitation (CPR) recommend uninterrupted chest compressions and continuous ventilation as soon as a patient is endotracheally intubated or a supraglottic airway (SGA) is positioned.

Recently, SGAs have been adopted by emergency medical services worldwide as the primary tool for airway management during CPR. SGAs offer limited protection against aspiration compared to endotracheal intubation (ETI) and may increase the risk of aspiration. A new ventilation mode (Chest Compression Synchronized Ventilation [CCSV]) is now available for resuscitation with uninterrupted chest compressions.

The study investigates the influence of non-synchronized bag-device-ventilation, intermittent positive pressure ventilation (IPPV), as recommended in the current resuscitation guidelines of the ERC (Vt = 5-6 mL/kg bw, AF = 10 min-1) and CCSV (pInsp = 40 mbar; RR = chest compression rate) with regard to achieving a sufficient tidal volume and the tightness of various SGA (laryngeal mask, iGel, laryngeal tube) and endotracheal intubation.

Gender, age, height and weight are documented (external post-mortem examination). The respective body donor is randomly assigned to a group. The grouping determines the order in which the means of airway management (SGA, ETI) are used.

Initial airway management is performed with an ETI with blockage of 30 mmH2O). The body donor is then bronchoscoped. A gastric tube is placed and the pressure probe to be used is calibrated if necessary. Positive pressure ventilation (pInsp = 40 mbar, positive end-expiratory pressure (PEEP) = 12 mbar, frequency = 10 min-1) is performed for 2 minutes to recruit the lungs. Vt is documented.

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
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •> 17 Years of Age

排除标准

  • •Adult respiratory distress syndrome (ARDS)
  • •Severe lung or thoracic injuries
  • •pneumothorax
  • •Abnormal airways
  • •Tracheostoma
  • •severe aspirations

研究组 & 干预措施

Bag-Device-Ventilation

Active Comparator

Ventilation with a Ventilation Bag

干预措施: Laryngeal mask (Other)

Bag-Device-Ventilation

Active Comparator

Ventilation with a Ventilation Bag

干预措施: I-Gel-Laryngeal Mask (Other)

CCSV

Active Comparator

Chest Compression Synchronized Ventilation

干预措施: Laryngeal tube (Other)

CCSV

Active Comparator

Chest Compression Synchronized Ventilation

干预措施: Laryngeal mask (Other)

IPPV

Active Comparator

Intermittend-Positive-Pressure-Ventilation

干预措施: Endotracheal Intubation (Other)

IPPV

Active Comparator

Intermittend-Positive-Pressure-Ventilation

干预措施: Laryngeal tube (Other)

IPPV

Active Comparator

Intermittend-Positive-Pressure-Ventilation

干预措施: Laryngeal mask (Other)

IPPV

Active Comparator

Intermittend-Positive-Pressure-Ventilation

干预措施: I-Gel-Laryngeal Mask (Other)

CCSV

Active Comparator

Chest Compression Synchronized Ventilation

干预措施: Endotracheal Intubation (Other)

CCSV

Active Comparator

Chest Compression Synchronized Ventilation

干预措施: I-Gel-Laryngeal Mask (Other)

Bag-Device-Ventilation

Active Comparator

Ventilation with a Ventilation Bag

干预措施: Endotracheal Intubation (Other)

Bag-Device-Ventilation

Active Comparator

Ventilation with a Ventilation Bag

干预措施: Laryngeal tube (Other)

结局指标

主要结局

Ventilation Pressure with different Airway devices in CCSV

时间窗: After beginning of ventilation up to 4 minutes each device

Expiratory Volume with different Airway Devices in IPPV

时间窗: After beginning of ventilation up to 4 minutes each device

Mean expiratory Volume with different Airway Devices in IPPV

次要结局

未报告次要终点

研究者

发起方
Gerrit Jansen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gerrit Jansen

Principal Investigator

Muehlenkreiskliniken, MKK

研究点 (1)

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