Intra-Arrest-Ventilation in Human Cadavers

NCT ID: NCT06306898

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-18

Study Completion Date

2024-08-21

Brief Summary

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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

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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.

Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized crossover design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IPPV

Intermittend-Positive-Pressure-Ventilation

Group Type ACTIVE_COMPARATOR

Endotracheal Intubation

Intervention Type OTHER

Ventilation with an endotracheal tube

Laryngeal tube

Intervention Type OTHER

Ventilation with an laryngeal tube

Laryngeal mask

Intervention Type OTHER

Ventilation with an laryngeal mask

I-Gel-Laryngeal Mask

Intervention Type OTHER

Ventilation with an I-Gel-laryngeal mask

CCSV

Chest Compression Synchronized Ventilation

Group Type ACTIVE_COMPARATOR

Endotracheal Intubation

Intervention Type OTHER

Ventilation with an endotracheal tube

Laryngeal tube

Intervention Type OTHER

Ventilation with an laryngeal tube

Laryngeal mask

Intervention Type OTHER

Ventilation with an laryngeal mask

I-Gel-Laryngeal Mask

Intervention Type OTHER

Ventilation with an I-Gel-laryngeal mask

Bag-Device-Ventilation

Ventilation with a Ventilation Bag

Group Type ACTIVE_COMPARATOR

Endotracheal Intubation

Intervention Type OTHER

Ventilation with an endotracheal tube

Laryngeal tube

Intervention Type OTHER

Ventilation with an laryngeal tube

Laryngeal mask

Intervention Type OTHER

Ventilation with an laryngeal mask

I-Gel-Laryngeal Mask

Intervention Type OTHER

Ventilation with an I-Gel-laryngeal mask

Interventions

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Endotracheal Intubation

Ventilation with an endotracheal tube

Intervention Type OTHER

Laryngeal tube

Ventilation with an laryngeal tube

Intervention Type OTHER

Laryngeal mask

Ventilation with an laryngeal mask

Intervention Type OTHER

I-Gel-Laryngeal Mask

Ventilation with an I-Gel-laryngeal mask

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \> 17 Years of Age

Exclusion Criteria

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

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role collaborator

Bielefeld University

OTHER

Sponsor Role collaborator

Gerrit Jansen

OTHER

Sponsor Role lead

Responsible Party

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Gerrit Jansen

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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JWK Minden

Minden, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Gelashvili T, Brand-Saberi B, Darvishali M, Hoyer A, Kolaparambil Varghese LJ, Kuehn V, Lohmann J, Neuhaus C, Schneider C, Trenkel J, Hinkelbein J, Jansen G. Efficacy of supraglottic airway devices in chest compression synchronized ventilation during continuous resuscitation: a prospective randomized cross-over cadaver study. Resuscitation. 2025 Sep 2:110795. doi: 10.1016/j.resuscitation.2025.110795. Online ahead of print.

Reference Type DERIVED
PMID: 40907692 (View on PubMed)

Other Identifiers

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IAV-2024-01

Identifier Type: -

Identifier Source: org_study_id

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