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Intra Arrest Ventilation in Human Cadavers II

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06885398
Enrollment
3
Registered
2025-03-20
Start date
2025-04-01
Completion date
2025-12-30
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilation During Resuscitation

Keywords

Cardiac arrest, Airway management, Cadaver, Heart diseases, Heart arrest, Death, cardiovascular diseases

Brief summary

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

OTHERtreatment

* 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

Sponsors

Muehlenkreiskliniken, MKK
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized crossover design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
gained tidalvolume with different airway devices in BIPAPAfter beginning of ventilation up to 4 minutes each devicemean expiratory volume compared to ideal tidalvolume gained by using different airway devices in BIPAP
gained ventilation volume with different airway devices in CPAP-ASBAfter beginning of ventilation up to 4 minutes each devicemean ventilation volume compared to ideal ventilation volume gained by using different airway devices in CPAP-ASB
occurred ventilation pressure with different airway devices in CCSVAfter beginning of ventilation up to 4 minutes each devicemean ventilation pressure needed to develope a sufficient tidalvolume by using different airway devices in CCSV

Secondary

MeasureTime frameDescription
Leakage volumeAfter beginning of ventilation up to 4 minutes each deviceLeakage volume during ventilation
Mean peak pressureAfter beginning of ventilation up to 4 minutes each deviceMean peak pressure during ventilation
Respiratory RateAfter beginning of ventilation up to 4 minutes each deviceRespiratory Rate during ventilation
Inspiratory pressureAfter beginning of ventilation up to 4 minutes each deviceInspiratory pressure during ventilation
Peak pressureAfter beginning of ventilation up to 4 minutes each devicePeak pressure during ventilation

Contacts

Primary ContactGerrit Jansen
gerrit.jansen@muehlenkreiskliniken.de004957179054401
Backup ContactJochen Hinkelbein
Jochen.hinkelbein@muehlenkreiskliniken.de004957179054401

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026