Intra-Arrest-Ventilation in Human Cadavers

NCT06306898 | Completed

• 1 other identifier: IAV-2024-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

ventilation; airway management

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

IPPV

ACTIVE COMPARATOR

Intermittend-Positive-Pressure-Ventilation

Other: Endotracheal Intubation; Other: Laryngeal tube; Other: Laryngeal mask; Other: I-Gel-Laryngeal Mask

CCSV

ACTIVE COMPARATOR

Chest Compression Synchronized Ventilation

Other: Endotracheal Intubation; Other: Laryngeal tube; Other: Laryngeal mask; Other: I-Gel-Laryngeal Mask

Bag-Device-Ventilation

ACTIVE COMPARATOR

Ventilation with a Ventilation Bag

Other: Endotracheal Intubation; Other: Laryngeal tube; Other: Laryngeal mask; Other: I-Gel-Laryngeal Mask

Interventions

Endotracheal Intubation OTHER

Ventilation with an endotracheal tube

Bag-Device-Ventilation; CCSV; IPPV

Laryngeal tube OTHER

Ventilation with an laryngeal tube

Bag-Device-Ventilation; CCSV; IPPV

Laryngeal mask OTHER

Ventilation with an laryngeal mask

Bag-Device-Ventilation; CCSV; IPPV

I-Gel-Laryngeal Mask OTHER

Ventilation with an I-Gel-laryngeal mask

Bag-Device-Ventilation; CCSV; IPPV

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 17 Years of Age

You may not qualify if:

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

Sponsors & Collaborators

• Gerrit Jansen: lead
• Ruhr University of Bochum: collaborator
• Bielefeld University: collaborator

Study Sites (1)

JWK Minden

Minden, North Rhine-Westphalia, 32429, Germany

Location

Related Publications (2)

• Lohmann J, Brand-Saberi B, Ullrich M, Gelashvili T, Hoyer A, Kolaparambil Varghese LJ, Kuehn V, Neuhaus C, Schneider C, Trenkel J, Hinkelbein J, Jansen G. Influence of different airway devices on intra-arrest ventilation during bag-valve-device ventilation - a prospective randomized controlled cadaver study. Crit Care. 2025 Dec 5;29(1):519. doi: 10.1186/s13054-025-05713-z.

  PMID: 41345669 DERIVED

• 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 Nov;216:110795. doi: 10.1016/j.resuscitation.2025.110795. Epub 2025 Sep 2.

  PMID: 40907692 DERIVED

MeSH Terms

Conditions

Heart Arrest; Respiratory Aspiration

Interventions

Intubation, Intratracheal; Laryngeal Masks

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized crossover design

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: March 18, 2024
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)