Cardiac ArrestNCT06306898
Intra-Arrest-Ventilation in Human Cadavers
A study testing Endotracheal Intubation, Laryngeal tube and Laryngeal mask in people with Cardiac Arrest, run by Gerrit Jansen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Endotracheal Intubation, Laryngeal tube and Laryngeal mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 18 Mar 2024to 21 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 17 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
1 site in 1 country.
About this study
Official title: Intra-Arrest-Ventilation - a Prospective Randomized Trial in Human Cadavers
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.
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 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
- Cardiac Arrest
- Being tested
- Endotracheal Intubation, Laryngeal tube, Laryngeal mask, I-Gel-Laryngeal Mask
- Keywords
- ventilation, airway management
- Medical subject headings
- Heart Arrest, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal IntubationOther
Ventilation with an endotracheal tube
Laryngeal tubeOther
Ventilation with an laryngeal tube
Laryngeal maskOther
Ventilation with an laryngeal mask
I-Gel-Laryngeal MaskOther
Ventilation with an I-Gel-laryngeal mask
| Study group | Role | What they receive |
|---|---|---|
| IPPV | Active comparator | Intermittend-Positive-Pressure-Ventilation Receives: Other: Endotracheal Intubation; Other: Laryngeal tube; Other: Laryngeal mask; Other: I-Gel-Laryngeal Mask |
| CCSV | Active comparator | Chest Compression Synchronized Ventilation Receives: Other: Endotracheal Intubation; Other: Laryngeal tube; Other: Laryngeal mask; Other: I-Gel-Laryngeal Mask |
| Bag-Device-Ventilation | Active comparator | Ventilation with a Ventilation Bag Receives: Other: Endotracheal Intubation; Other: Laryngeal tube; Other: Laryngeal mask; Other: I-Gel-Laryngeal Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expiratory Volume with different Airway Devices in IPPV
Mean expiratory Volume with different Airway Devices in IPPV
Measured: After beginning of ventilation up to 4 minutes each device
Ventilation Pressure with different Airway devices in CCSV
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 posted12 Mar 2024
- Study start18 Mar 2024
- Primary completion21 Aug 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerrit Jansen
- Sponsor type
- University, hospital or other
- Collaborators
- Ruhr University of Bochum, Bielefeld University
- Responsible party
- Sponsor-investigator, Gerrit Jansen, Muehlenkreiskliniken, MKK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306898
- Sponsor's protocol ID
- IAV-2024-01
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2024
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41345669Gelashvili 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.
PubMed 40907692
Study at a glance
From the registry record, last updated by the sponsor on 17 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
- ClinicalTrials.gov ID
- NCT06306898
- Acronym / sponsor ID
- IAV-2024-01
- Conditions
- Cardiac Arrest
- Keywords
- ventilation, airway management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Gerrit JansenUniversity, hospital or other
- Collaborators
- Ruhr University of Bochum, Bielefeld University
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 12 Mar 2024 (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 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
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.
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 |
|---|---|---|
| IPPV | Active comparator | Other: Endotracheal Intubation, Other: Laryngeal tube, Other: Laryngeal mask, Other: I-Gel-Laryngeal MaskIntermittend-Positive-Pressure-Ventilation |
| CCSV | Active comparator | Other: Endotracheal Intubation, Other: Laryngeal tube, Other: Laryngeal mask, Other: I-Gel-Laryngeal MaskChest Compression Synchronized Ventilation |
| Bag-Device-Ventilation | Active comparator | Other: Endotracheal Intubation, Other: Laryngeal tube, Other: Laryngeal mask, Other: I-Gel-Laryngeal MaskVentilation with a Ventilation Bag |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- > 17 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 |
|---|---|---|
| Endotracheal IntubationVentilation with an endotracheal tube | Other | Bag-Device-Ventilation, CCSV, IPPV |
| Laryngeal tubeVentilation with an laryngeal tube | Other | Bag-Device-Ventilation, CCSV, IPPV |
| Laryngeal maskVentilation with an laryngeal mask | Other | Bag-Device-Ventilation, CCSV, IPPV |
| I-Gel-Laryngeal MaskVentilation with an I-Gel-laryngeal mask | Other | Bag-Device-Ventilation, CCSV, IPPV |
Primary outcome
Expiratory Volume with different Airway Devices in IPPV
Time frame: After beginning of ventilation up to 4 minutes each device
Mean expiratory Volume with different Airway Devices in IPPV
Ventilation Pressure with different Airway devices in CCSV
Time frame: After beginning of ventilation up to 4 minutes each device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 41345669Lohmann 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.
- Derived from this study: PubMed 40907692Gelashvili 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal Intubation, Laryngeal tube and Laryngeal mask in people with Cardiac Arrest, run by Gerrit Jansen at 1 site in Germany.
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: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expiratory Volume with different Airway Devices in IPPV (time frame: After beginning of ventilation up to 4 minutes each device). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06306898, which also lists 2 linked publications.
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 17 Mar 2025.