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Not yet recruiting NCT06885398

Intra Arrest Ventilation in Human Cadavers II

No phase Interventional Ventilation During Resuscitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: treatment.
Who it may be relevant to
Registry conditions: Ventilation During Resuscitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other treatment
    * 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 outcome measures

  • gained tidalvolume with different airway devices in BIPAP [Time frame: After beginning of ventilation up to 4 minutes each device]
  • gained ventilation volume with different airway devices in CPAP-ASB [Time frame: After beginning of ventilation up to 4 minutes each device]
  • occurred ventilation pressure with different airway devices in CCSV [Time frame: After beginning of ventilation up to 4 minutes each device]
Secondary outcome measures (5)
  • Mean peak pressure [Time frame: After beginning of ventilation up to 4 minutes each device]
  • Inspiratory pressure [Time frame: After beginning of ventilation up to 4 minutes each device]
  • Peak pressure [Time frame: After beginning of ventilation up to 4 minutes each device]
  • Leakage volume [Time frame: After beginning of ventilation up to 4 minutes each device]
  • Respiratory Rate [Time frame: After beginning of ventilation up to 4 minutes each device]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06885398 · 2025-1341

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗