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Completed

NCT Number: NCT06306898

Intra-Arrest-Ventilation in Human Cadavers

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

JWK Minden

Minden, North Rhine-Westphalia, 32429, Germany

About this study

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.

Mechanical cardiopulmonary resuscitation (CPR) is then performed for minutes (4 cycles) using the mechanical chest compression device in accordance with ERC 2015. Ventilation pressure and flow curves are continuously recorded by the respirator (Medumat Standard², Weinmann GmbH). Leaks are detected via the automatically initiated ventilation curves, measured and recorded by the ventilator. Ventilation takes place for 4 minutes with bad-device-ventilation, 4 minutes in IPPV mode and 4 minutes in CCSV mode. At the end of the two cycles, the body donor is intubated with one of the remaining airway devices, and the lungs are recruited again and mechanical CPR is performed again for 12 minutes using the 3 ventilation modes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 17 Years of Age

Exclusion criteria

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

Treatment and study plan

Endotracheal Intubation

Other

Ventilation with an endotracheal tube

Laryngeal tube

Other

Ventilation with an laryngeal tube

Laryngeal mask

Other

Ventilation with an laryngeal mask

I-Gel-Laryngeal Mask

Other

Ventilation with an I-Gel-laryngeal mask

Primary outcomes

  1. Expiratory Volume with different Airway Devices in IPPV

    Time frame: After beginning of ventilation up to 4 minutes each device

    Mean expiratory Volume with different Airway Devices in IPPV

  2. Ventilation Pressure with different Airway devices in CCSV

    Time frame: After beginning of ventilation up to 4 minutes each device

Sponsors and collaborators

Lead sponsor

Gerrit Jansen

Other

Collaborators

  • Bielefeld University
  • Ruhr University of Bochum

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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