Clinical trial NCT06306898: Intra-Arrest-Ventilation in Human Cadavers
Official title: Intra-Arrest-Ventilation - a Prospective Randomized Trial in Human Cadavers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: ventilation
airway management
Lead sponsor: Muehlenkreiskliniken, MKK
Sponsor class: OTHER
Collaborators: name: Ruhr University of Bochum
name: Bielefeld University
First posted: 2024-03-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized crossover design
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* \> 17 Years of Age

Exclusion Criteria:

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

Primary outcomes:
measure: Expiratory Volume with different Airway Devices in IPPV
timeFrame: After beginning of ventilation up to 4 minutes each device
measure: Ventilation Pressure with different Airway devices in CCSV
timeFrame: After beginning of ventilation up to 4 minutes each device
Secondary outcomes:
Other outcomes:
Locations:
city: Minden
country: Germany
facility: JWK Minden
state: NRW
Study officials:
References: