Intra Arrest Ventilation in Human Cadavers II

Intra-Arrest-Ventilation - a Prospective Randomized Trial 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventilation During Resuscitation
• Intervention / Treatment: Other: treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerrit Jansen; Phone Number: 004957179054401; Email: gerrit.jansen@muehlenkreiskliniken.de
• Study Contact Backup: Name: Jochen Hinkelbein; Phone Number: 004957179054401; Email: Jochen.hinkelbein@muehlenkreiskliniken.de

Participation Criteria

Eligibility Criteria

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

Description

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

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: BIPAP (Bi-Level positive airway pressure)	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
Active Comparator: CPAP ASB (continouos positive airway pressure with assisted spontaneous breathing)	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
Active Comparator: CCSV (Chest Compression Synchronized Ventilation)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gained tidalvolume with different airway devices in BIPAP	mean expiratory volume compared to ideal tidalvolume gained by using different airway devices in BIPAP	After beginning of ventilation up to 4 minutes each device
gained ventilation volume with different airway devices in CPAP-ASB	mean ventilation volume compared to ideal ventilation volume gained by using different airway devices in CPAP-ASB	After beginning of ventilation up to 4 minutes each device
occurred ventilation pressure with different airway devices in CCSV	mean ventilation pressure needed to develope a sufficient tidalvolume by using different airway devices in CCSV	After beginning of ventilation up to 4 minutes each device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean peak pressure	Mean peak pressure during ventilation	After beginning of ventilation up to 4 minutes each device
Inspiratory pressure	Inspiratory pressure during ventilation	After beginning of ventilation up to 4 minutes each device
Peak pressure	Peak pressure during ventilation	After beginning of ventilation up to 4 minutes each device
Leakage volume	Leakage volume during ventilation	After beginning of ventilation up to 4 minutes each device
Respiratory Rate	Respiratory Rate during ventilation	After beginning of ventilation up to 4 minutes each device

Collaborators and Investigators

• Sponsor: Muehlenkreiskliniken, MKK

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 6, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Cardiac arrest; cardiovascular diseases; Heart arrest; Heart diseases; Death; Airway management; Cadaver
• Additional Relevant MeSH Terms: Pathologic Processes; Death; Cadaver
• Other Study ID Numbers: 2025-1341

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