Intra-Arrest-Ventilation in Human Cadavers

Intra-Arrest-Ventilation - a Prospective Randomized Trial 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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: Endotracheal Intubation; Other: Laryngeal tube; Other: Laryngeal mask; Other: I-Gel-Laryngeal Mask

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Minden, NRW, Germany, 32429
      • JWK Minden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• > 17 Years of Age

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IPPV; Intermittend-Positive-Pressure-Ventilation	Other: Endotracheal Intubation; Ventilation with an endotracheal tube; Other: Laryngeal tube; Ventilation with an laryngeal tube; Other: Laryngeal mask; Ventilation with an laryngeal mask; Other: I-Gel-Laryngeal Mask; Ventilation with an I-Gel-laryngeal mask
Active Comparator: CCSV; Chest Compression Synchronized Ventilation	Other: Endotracheal Intubation; Ventilation with an endotracheal tube; Other: Laryngeal tube; Ventilation with an laryngeal tube; Other: Laryngeal mask; Ventilation with an laryngeal mask; Other: I-Gel-Laryngeal Mask; Ventilation with an I-Gel-laryngeal mask
Active Comparator: Bag-Device-Ventilation; Ventilation with a Ventilation Bag	Other: Endotracheal Intubation; Ventilation with an endotracheal tube; Other: Laryngeal tube; Ventilation with an laryngeal tube; Other: Laryngeal mask; Ventilation with an laryngeal mask; Other: I-Gel-Laryngeal Mask; Ventilation with an I-Gel-laryngeal mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expiratory Volume with different Airway Devices in IPPV	Mean expiratory Volume with different Airway Devices in IPPV	After beginning of ventilation up to 4 minutes each device
Ventilation Pressure with different Airway devices in CCSV		After beginning of ventilation up to 4 minutes each device

Collaborators and Investigators

• Sponsor: Gerrit Jansen
• Collaborators: Ruhr University of Bochum; Bielefeld University

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2024
• Primary Completion (Actual): August 21, 2024
• Study Completion (Actual): August 21, 2024

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: ventilation; airway management
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Death; Heart Arrest; Cadaver
• Other Study ID Numbers: IAV-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No