Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06885398

Intra Arrest Ventilation in Human Cadavers II

The study investigates the influence of three types of ventilation mode by using Bi-Level positive airway pressure (pinsp 20 mbar, PEEP 5, AF 10/min) with two different types of ventilators ( Medumat vs. MeduVENT ), Continuous positive airway pressure (PEEP 5, AF 10/min, ASB 10) and Chest Compression Synchronized Ventilation (pInsp = 30 vs. 60 mbar; respiratory rate = chest compression rate, PEEP 5) 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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 three types of ventilation mode by using Bi-Level positive airway pressure with two kind ventilators (pinsp 20 mbar, PEEP 5, AF 10/min), Continuous positive airway pressure (PEEP 5, AF 10/min, ASB 10) and Chest Compression Synchronized Ventilation (pInsp = 30 vs. 60 mbar; respiratory rate = chest compression rate, PEEP 5) 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.

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 40 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 = 35 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 and MeduVENT by the company Weinmann GmbH). Leaks are detected via the automatically initiated ventilation curves, measured and recorded by the ventilator. Ventilation takes place for 4 minutes with CPAP ASB, 4 minutes in BIPAP mode with Medumat, 4 minutes with MeduVENT and 4 minutes in CCSV mode with an pinsp of 30 and 4 minutes with 60 mbar . At the end of the cycle, 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 20 minutes using the 3 ventilation modes. All in all the time durance of CPR for one donor will be 100 minutes by using all four airway devices.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • more than 18 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

Treatment

Other
  • Endotracheal Tube Ventilation with an endotracheal tub
  • Laryngeal tube Ventilation with a laryngeal tube
  • Laryngeal mask Ventilation with a laryngeal mask
  • I-Gel-Laryngeal Mask Ventilation with an I-Gel-laryngeal mask

Primary outcomes

  1. gained tidalvolume with different airway devices in BIPAP

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

    mean expiratory volume compared to ideal tidalvolume gained by using different airway devices in BIPAP

  2. gained ventilation volume with different airway devices in CPAP-ASB

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

    mean ventilation volume compared to ideal ventilation volume gained by using different airway devices in CPAP-ASB

  3. occurred ventilation pressure with different airway devices in CCSV

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

    mean ventilation pressure needed to develope a sufficient tidalvolume by using different airway devices in CCSV

Secondary outcomes

  1. Mean peak pressure

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

    Mean peak pressure during ventilation

  2. Inspiratory pressure

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

    Inspiratory pressure during ventilation

  3. Peak pressure

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

    Peak pressure during ventilation

  4. Leakage volume

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

    Leakage volume during ventilation

  5. Respiratory Rate

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

    Respiratory Rate during ventilation

Study contacts

Contact information is provided by the study sponsor or research team.

Gerrit Jansen

CONTACT

[email protected]

004957179054401

Jochen Hinkelbein

CONTACT

[email protected]

004957179054401

Sponsors and collaborators

Lead sponsor

Muehlenkreiskliniken, MKK

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2025
Registry last updated
Mar 20, 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.

Published trials that share one or more normalized conditions with this study.