NCT06885398

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

March 20, 2025

Status Verified

February 1, 2025

Enrollment Period

5 days

First QC Date

February 26, 2025

Last Update Submit

March 17, 2025

Conditions

Ventilation During Resuscitation

Keywords

Cardiac arrestAirway managementCadaverHeart diseasesHeart arrestDeathcardiovascular diseases

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Mean peak pressure

    After beginning of ventilation up to 4 minutes each device

  • Inspiratory pressure

    After beginning of ventilation up to 4 minutes each device

  • Peak pressure

    After beginning of ventilation up to 4 minutes each device

  • Leakage volume

    After beginning of ventilation up to 4 minutes each device

  • Respiratory Rate

    After beginning of ventilation up to 4 minutes each device

Study Arms (3)

BIPAP (Bi-Level positive airway pressure)

ACTIVE COMPARATOR
Other: treatment

CPAP ASB (continouos positive airway pressure with assisted spontaneous breathing)

ACTIVE COMPARATOR
Other: treatment

CCSV (Chest Compression Synchronized Ventilation)

ACTIVE COMPARATOR
Other: treatment

Interventions

treatmentOTHER

* 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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 18 years of age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart ArrestCadaverHeart DiseasesDeathCardiovascular Diseases

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Gerrit Jansen

CONTACT

004957179054401gerrit.jansen@muehlenkreiskliniken.de

Jochen Hinkelbein

CONTACT

004957179054401Jochen.hinkelbein@muehlenkreiskliniken.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomized crossover design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2025

First Posted

March 20, 2025

Study Start

April 1, 2025

Primary Completion

April 6, 2025

Study Completion

December 30, 2025

Last Updated

March 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share