Ventilation During ResuscitationNCT06885398
Intra Arrest Ventilation in Human Cadavers II
A study testing treatment in people with Ventilation During Resuscitation, run by Muehlenkreiskliniken, MKK.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventilation During Resuscitation
- What is being tested?
- treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- more than 18 years of age
Who cannot join
- Adult respiratory distress syndrome (ARDS)
- Severe lung or thoracic injuries
- Pneumothorax
- Abnormal airways
- Tracheostoma
- severe aspirations
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventilation During Resuscitation
- Being tested
- treatment
- Keywords
- Cardiac arrest, Airway management, Cadaver, Heart diseases, Heart arrest, Death, cardiovascular diseases
- Medical subject headings
- Heart Arrest, Cadaver, Heart Diseases, Death, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| BIPAP (Bi-Level positive airway pressure) | Active comparator | Not described Receives: Other: treatment |
| CPAP ASB (continouos positive airway pressure with assisted spontaneous breathing) | Active comparator | Not described Receives: Other: treatment |
| CCSV (Chest Compression Synchronized Ventilation) | Active comparator | Not described Receives: Other: treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
gained tidalvolume with different airway devices in BIPAP
mean expiratory volume compared to ideal tidalvolume gained by using different airway devices in BIPAP
Measured: 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
Measured: 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
Measured: After beginning of ventilation up to 4 minutes each device
Secondary outcomes (5)
Mean peak pressure
Mean peak pressure during ventilation
Measured: After beginning of ventilation up to 4 minutes each device
Inspiratory pressure
Inspiratory pressure during ventilation
Measured: After beginning of ventilation up to 4 minutes each device
Peak pressure
Peak pressure during ventilation
Measured: After beginning of ventilation up to 4 minutes each device
Leakage volume
Leakage volume during ventilation
Measured: After beginning of ventilation up to 4 minutes each device
Respiratory Rate
Respiratory Rate during ventilation
Measured: After beginning of ventilation up to 4 minutes each device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion6 Apr 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation During ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover design
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muehlenkreiskliniken, MKK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885398
- Sponsor's protocol ID
- 2025-1341
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Arrest-Ventilation - a Prospective Randomized Trial in Human Cadavers II
- ClinicalTrials.gov ID
- NCT06885398
- Acronym / sponsor ID
- 2025-1341
- Conditions
- Ventilation During Resuscitation
- Keywords
- Cardiac arrest, Airway management, Cadaver, Heart diseases, Heart arrest, Death, cardiovascular diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Muehlenkreiskliniken, MKKUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 6 Apr 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- more than 18 years of age
Key exclusion criteria (6 listed)
- Adult respiratory distress syndrome (ARDS)
- Severe lung or thoracic injuries
- Pneumothorax
- Abnormal airways
- Tracheostoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | BIPAP (Bi-Level positive airway pressure), CCSV (Chest Compression Synchronized Ventilation), CPAP ASB (continouos positive airway pressure with assisted spontaneous breathing) |
Primary outcome
gained tidalvolume with different airway devices in BIPAP
Time frame: After beginning of ventilation up to 4 minutes each device
mean expiratory volume compared to ideal tidalvolume gained by using different airway devices in BIPAP
gained ventilation volume with different airway devices in CPAP-ASB
Time frame: After beginning of ventilation up to 4 minutes each device
mean ventilation volume compared to ideal ventilation volume gained by using different airway devices in CPAP-ASB
occurred ventilation pressure with different airway devices in CCSV
Time frame: After beginning of ventilation up to 4 minutes each device
mean ventilation pressure needed to develope a sufficient tidalvolume by using different airway devices in CCSV
5 secondary outcomes
Mean peak pressure
Time frame: After beginning of ventilation up to 4 minutes each device
Inspiratory pressure
Time frame: After beginning of ventilation up to 4 minutes each device
Peak pressure
Time frame: After beginning of ventilation up to 4 minutes each device
Leakage volume
Time frame: After beginning of ventilation up to 4 minutes each device
Respiratory Rate
Time frame: After beginning of ventilation up to 4 minutes each device
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing treatment in people with Ventilation During Resuscitation, run by Muehlenkreiskliniken, MKK.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerrit Jansen (004957179054401, gerrit.jansen@muehlenkreiskliniken.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gained tidalvolume with different airway devices in BIPAP (time frame: After beginning of ventilation up to 4 minutes each device). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.