Cardio Respiratory ArrestVICANCT04657393
Ventilation in Cardiac Arrest
A study testing mechanical ventilation in people with Cardio Respiratory Arrest and Cardiac Death, run by Medical University of Graz at 1 site in Austria.
Trial summary
Over the last decades, research in cardiopulmonary resuscitation was primarily focused on uninterrupted chest compressions to restore sufficient circulation. Ventilation during ongoing chest compressions was regarded as potentially deleterious and thus not given any major scientific focus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardio Respiratory Arrest, Cardiac Death, Ventilation Therapy; Complications
- What is being tested?
- mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2019to 30 Nov 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- out-of-hospital cardiac arrest (OHCA)
- cardio-pulmonary resuscitation (CPR) efforts
- endotracheal intubation
Who cannot join
- children and adolescents (age<18 years at inclusion)
- pregnant women
- previous documented lack of legal capacity
- previous documented refusal to participate in trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Comparison of Ventilation Patterns During Cardio-Pulmonary Resuscitation for Out-Of-Hospital Cardiac Arrest
Over the last decades, research in cardiopulmonary resuscitation was primarily focused on uninterrupted chest compressions to restore sufficient circulation. Ventilation during ongoing chest compressions was regarded as potentially deleterious and thus not given any major scientific focus. Current guidelines advise that ventilation be monitored by end-tidal CO2 and emphasize that hyperventilation be avoided. Recent findings from arterial blood gas analyses showed high levels of arterial pCO2, resulting in a frequent occurrence of hypercapnic acidosis, which may be caused by iatrogenic hypoventilation. Ventilation during ongoing chest compressions can be hard to achieve, as nearly every breath may be terminated by simultaneous chest compressions. In case of bag ventilation the applied tidal volumes have not yet been measured und mechanical ventilators so far were not able to ventilate during chest compressions, because pressure limit settings induced termination of inspiration.
The aim of this study is to provide patients with the best possible ventilation, even under ongoing chest compressions. Patients are ventilated with a new turbine-driven ventilator (Monnal T60, Air Liquide, France), which can deliver adequate tidal volumes within a very short inspiratory phase due to the inspiratory flow of > 200l/min. Thus, in deviation from the current recommendations, the ventilation rate can be doubled to 20/min, so that inspiration coincides with cardiac massage less often. The study compares effective ventilation volumes applied by two regimes, 10 breaths/min and 20/min.
Read the detailed description
Restoration of circulation is undoubtedly the basis of success in cardiopulmonary resuscitation (CPR). Current guidelines on CPR require that hyperventilation be avoided during CPR. Blood gas analysis results from the "BABICA trial" demonstrate that more than 90% of patients have highly elevated levels of pCO2 and are acidotic, mainly due to hypercapnia. No hyperventilated or alkalotic patients were found during CPR. Furthermore, higher pO2 values were found to be associated with improved outcomes. Current recommendations to limit ventilation frequency to 10/min was also critically questioned in a recent study from Belgium, which did not show any positive effect of low respiration rate compared to higher ones, cut-off 10/min. There are currently no clinical trials addressing optimal tidal volumes or minute volumes during CPR.
A major obstacle to continuous measurement of respiratory minute volumes during CPR are ongoing chest compressions. In a retrospective study in which respiratory volumes were derived from bioimpedance curves, better outcomes were found in the group of more frequent ventilations. Common machine ventilators display set values, while expiratory volumes are averaged and may be overlaid by volume shifts of cardiac massage. In a recent study, investigators analyzed flow curves, where each breath can be evaluated individually and volumes can be derived correctly using dedicated software. We were able to test this method on a comparative study of three ventilators study on anatomical cadavers.
This study aims to detect whether a higher rate of ventilation using a turbine driven ventilator is able to provide higher breathing volumes during ongoing chest compressions in individuals suffering from out-of-hospital cardiac arrest (OHCA). Higher ventilation and oxygenation parameters as well as optimized acid-base-balance and increased rates of ROSC are expected.
Patient care (chest compressions, venous access, endotracheal intubation, application of drugs, defibrillation if necessary) is conducted according to current recommendation for Advanced Life Support (ALS) as issued by the European Resuscitation Council (ERC). Ventilation is performed at one of two patterns: the control group is ventilated at 10 breaths per minute, the intervention group is ventilated at 20 breaths per minute. Patterns are alternating according to calendar week. After successful endotracheal intubation mechanical ventilation is carried out using a turbine-driven ventilator (Monnal T60, AirLiquide, France). Ventilator settings are pre-set: respiratory frequency is set at 10/min or 20/min (see above), other ventilator parameters remain identical: Positive End-Expiratory Pressure (PEEP) 0 mmHg, FiO2 1,0, tidal volume 6ml/kg ideal body weight [men: 50+(0.91x(body length-152.4)), women: 45+(0.91y(body length-152.4))]. These calculations can be performed on the ventilator itself by entering patients' age, height and gender. Chest compressions are carried out without interruptions and without considerations regarding the respiratory cycle.
- Being tested
- mechanical ventilation
- Keywords
- cardiopulmonary resuscitation, mechanical ventilation, Gas exchange
- Medical subject headings
- Heart Arrest, Death, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationProcedure or surgery
change of ventilation frequency
| Study group | Role | What they receive |
|---|---|---|
| Alternative Ventilation Rate | Active comparator | ventilation is performed at 20 breaths/min Receives: Procedure: mechanical ventilation |
| Conventional Ventilation Rate | Active comparator | ventilation is performed at 10 breaths/min Receives: Procedure: mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minute ventilation
exspiratory ventilatory volume per minute
Measured: during ongoing chest compressions
adequacy of ventilation - pH
Evaluation of ventilation success per using arterial blood gas analyses (pH)
Measured: during ongoing cardiopulmonary resuscitation
adequacy of ventilation - paCO2
Evaluation of ventilation success per using arterial blood gas analyses (paCO2)
Measured: during ongoing cardiopulmonary resuscitation
Secondary outcomes (1)
ROSC
Return of Spontaneous Circulation
Measured: during prehospital resuscitation efforts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Jun 2019
- Primary completion31 Oct 2021
- Study completion30 Nov 2021
Why it stopped: slow inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardio Respiratory 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
- Parallel groups
- Model description
- prospective, randomized, parallel study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerhard Prause, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657393
- Sponsor's protocol ID
- VICA
- Acronym
- VICA
- Status last verified
- Nov 2022
- First submitted
- 1 Dec 2020
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prause G, Zoidl P, Eichinger M, Eichlseder M, Orlob S, Ruhdorfer F, Honnef G, Metnitz PGH, Zajic P. Mechanical ventilation with ten versus twenty breaths per minute during cardio-pulmonary resuscitation for out-of-hospital cardiac arrest: A randomised controlled trial. Resuscitation. 2023 Jun;187:109765. doi: 10.1016/j.resuscitation.2023.109765. Epub 2023 Mar 15.
PubMed 36931453
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Ventilation Patterns During Cardio-Pulmonary Resuscitation for Out-Of-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04657393
- Acronym / sponsor ID
- VICA / VICA
- Keywords
- cardiopulmonary resuscitation, mechanical ventilation, Gas exchange
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow inclusion
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 8 Dec 2020 (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.
Over the last decades, research in cardiopulmonary resuscitation was primarily focused on uninterrupted chest compressions to restore sufficient circulation. Ventilation during ongoing chest compressions was regarded as potentially deleterious and thus not given any major scientific focus. Current guidelines advise that ventilation be monitored by end-tidal CO2 and emphasize that hyperventilation be avoided. Recent findings from arterial blood gas analyses showed high levels of arterial pCO2, resulting in a frequent occurrence of hypercapnic acidosis, which may be caused by iatrogenic hypoventilation. Ventilation during ongoing chest compressions can be hard to achieve, as nearly every breath may be terminated by simultaneous chest compressions. In case of bag ventilation the applied tidal volumes have not yet been measured und mechanical ventilators so far were not able to ventilate during chest compressions, because pressure limit settings induced termination of inspiration.
The aim of this study is to provide patients with the best possible ventilation, even under ongoing chest compressions. Patients are ventilated with a new turbine-driven ventilator (Monnal T60, Air Liquide, France), which can deliver adequate tidal volumes within a very short inspiratory phase due to the inspiratory flow of > 200l/min. Thus, in deviation from the current recommendations, the ventilation rate can be doubled to 20/min, so that inspiration coincides with cardiac massage less often. The study compares effective ventilation volumes applied by two regimes, 10 breaths/min and 20/min.
Detailed description
Restoration of circulation is undoubtedly the basis of success in cardiopulmonary resuscitation (CPR). Current guidelines on CPR require that hyperventilation be avoided during CPR. Blood gas analysis results from the "BABICA trial" demonstrate that more than 90% of patients have highly elevated levels of pCO2 and are acidotic, mainly due to hypercapnia. No hyperventilated or alkalotic patients were found during CPR. Furthermore, higher pO2 values were found to be associated with improved outcomes. Current recommendations to limit ventilation frequency to 10/min was also critically questioned in a recent study from Belgium, which did not show any positive effect of low respiration rate compared to higher ones, cut-off 10/min. There are currently no clinical trials addressing optimal tidal volumes or minute volumes during CPR.
A major obstacle to continuous measurement of respiratory minute volumes during CPR are ongoing chest compressions. In a retrospective study in which respiratory volumes were derived from bioimpedance curves, better outcomes were found in the group of more frequent ventilations. Common machine ventilators display set values, while expiratory volumes are averaged and may be overlaid by volume shifts of cardiac massage. In a recent study, investigators analyzed flow curves, where each breath can be evaluated individually and volumes can be derived correctly using dedicated software. We were able to test this method on a comparative study of three ventilators study on anatomical cadavers.
This study aims to detect whether a higher rate of ventilation using a turbine driven ventilator is able to provide higher breathing volumes during ongoing chest compressions in individuals suffering from out-of-hospital cardiac arrest (OHCA). Higher ventilation and oxygenation parameters as well as optimized acid-base-balance and increased rates of ROSC are expected.
Patient care (chest compressions, venous access, endotracheal intubation, application of drugs, defibrillation if necessary) is conducted according to current recommendation for Advanced Life Support (ALS) as issued by the European Resuscitation Council (ERC). Ventilation is performed at one of two patterns: the control group is ventilated at 10 breaths per minute, the intervention group is ventilated at 20 breaths per minute. Patterns are alternating according to calendar week. After successful endotracheal intubation mechanical ventilation is carried out using a turbine-driven ventilator (Monnal T60, AirLiquide, France). Ventilator settings are pre-set: respiratory frequency is set at 10/min or 20/min (see above), other ventilator parameters remain identical: Positive End-Expiratory Pressure (PEEP) 0 mmHg, FiO2 1,0, tidal volume 6ml/kg ideal body weight [men: 50+(0.91x(body length-152.4)), women: 45+(0.91y(body length-152.4))]. These calculations can be performed on the ventilator itself by entering patients' age, height and gender. Chest compressions are carried out without interruptions and without considerations regarding the respiratory cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, randomized, parallel study
| Arm | Type | Receives |
|---|---|---|
| Alternative Ventilation Rate | Active comparator | Procedure: mechanical ventilationventilation is performed at 20 breaths/min |
| Conventional Ventilation Rate | Active comparator | Procedure: mechanical ventilationventilation is performed at 10 breaths/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- out-of-hospital cardiac arrest (OHCA)
- cardio-pulmonary resuscitation (CPR) efforts
- endotracheal intubation
Key exclusion criteria (4 listed)
- children and adolescents (age<18 years at inclusion)
- pregnant women
- previous documented lack of legal capacity
- previous documented refusal to participate in trials
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 |
|---|---|---|
| mechanical ventilationchange of ventilation frequency | Procedure or surgery | Alternative Ventilation Rate, Conventional Ventilation Rate |
Primary outcome
Minute ventilation
Time frame: during ongoing chest compressions
exspiratory ventilatory volume per minute
adequacy of ventilation - pH
Time frame: during ongoing cardiopulmonary resuscitation
Evaluation of ventilation success per using arterial blood gas analyses (pH)
adequacy of ventilation - paCO2
Time frame: during ongoing cardiopulmonary resuscitation
Evaluation of ventilation success per using arterial blood gas analyses (paCO2)
1 secondary outcome
ROSC
Time frame: during prehospital resuscitation efforts
Results and safety
The study was stopped early (reason given: slow inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Derived from this study: PubMed 36931453Prause G, Zoidl P, Eichinger M, Eichlseder M, Orlob S, Ruhdorfer F, Honnef G, Metnitz PGH, Zajic P. Mechanical ventilation with ten versus twenty breaths per minute during cardio-pulmonary resuscitation for out-of-hospital cardiac arrest: A randomised controlled trial. Resuscitation. 2023 Jun;187:109765. doi: 10.1016/j.resuscitation.2023.109765. Epub 2023 Mar 15.
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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.
Gerhard Prause, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical ventilation in people with Cardio Respiratory Arrest and Cardiac Death, run by Medical University of Graz at 1 site in Austria.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 29 Nov 2022. 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 Austria. 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 was stopped early (reason given: slow inclusion). Results are not available in the source record.
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?
Minute ventilation (time frame: during ongoing chest compressions). 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?
On the ClinicalTrials.gov record for NCT04657393, which also lists 1 linked publication.
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 29 Nov 2022.