AzTrials
AzTrials

Cardiopulmonary ArrestNCT06175689

Evaluating the Performance of Invasive Ventilation During Specialized CPR

An observational study of Cardiopulmonary Arrest and Mechanical Ventilation Complication, run by University Hospital, Angers.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Describe the ventilation patterns, describe the evolution of ventilation over time and describe the safety data for two strategies of ventilation (volume or pression modes) during specialized cardiopulmonary resuscitation of pre-hospital cardiorespiratory arrest: an observational and multicentre study. Read more about this study

Who is it for?
Ages 18 years and older
How many people
400 participants
Where
No sites listed yet
Study dates
10 Dec 2023to 1 Jan 2025
Phase
Observational
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
  • No healthy volunteers
  • Adult, Older adult

Study population: The population studied is that of out-of-hospital cardiorespiratory arrests managed by the emergency medicine prehospital medical teams (SMUR) of the four inclusion centers and meeting the inclusion criteria.

Who may be able to join

  • Adult patients (age 18 or older)
  • With out-of-hospital cardiorespiratory arrest
  • For which specialized cardiopulmonary resuscitation is indicated and started
  • Supported by the SMUR of the Angers University Hospital of Angers, the Necker-Enfants malades University Hospital, the Grenoble University Hospital and the hospital of Annecy-Genevois
  • And for which invasive mechanical ventilation on Monnal T60 transport respirator is started

Who cannot join

  • patients for whom it is decided not to perform invasive ventilation and
  • Patients opposed to participating in research
  • Patients with a limitation of active therapies
  • Patients who are not members or beneficiaries of a social security scheme

Trial locations and contacts

No sites are listed yet.

Francois Morin, MD, MSc contact

0666431611

francois.morin@chu-angers.fr

About this study

Official title: Evaluating the Performance of Invasive Ventilation During Specialized Cardiopulmonary Arrest Resuscitation: a Multicentre Observational Study

Describe the ventilation patterns, describe the evolution of ventilation over time and describe the safety data for two strategies of ventilation (volume or pression modes) during specialized cardiopulmonary resuscitation of pre-hospital cardiorespiratory arrest: an observational and multicentre study.

Read the detailed description

Out-of-hospital cardiac arrest is a real public health issue, whose annual incidence in Europe is 67 to 170 per 110,000 inhabitants, but whose survival remains extremely low, of the order of 4.6 to 8%. Rapid implementation of the survival chain and then specialized resuscitation is therefore essential. The recommendations of the 2020 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care and the 2021 European Rescucitation Council Guidelines recently reaffirmed the quality criteria for cardiopulmonary resuscitation (CPR) basic. Thus, during this CPR, rescuers must perform optimal chest compressions, that is, at a depth of 5 cm without exceeding 6 cm and at a frequency of 100 to 120/min with the minimum interruption time. Decompression must also be of quality.

As regards the ventilation of cardiac arrest, areas of uncertainty persist. This can be done using a bag valve mask (BAVU) or a respirator, regardless of the environment. The oxygen inspired fraction (FiO2) should be as high as possible during CPR. In the case of specialized and medicalized CPR, artificial ventilation must be implemented as soon as possible. Once the orotracheal intubation is performed, the clinician must mechanically ventilate the patient at a frequency of 10 breaths per minute without interrupting chest compressions. A ventilation strategy with reduced tidal volume (6-7 mL.kg-1 weight predicted) is preferred, associated with a low positive tele-expiratory pressure (PEEP) of 0 to 5 cmH20. Despite these clear recommendations, a heterogeneity of ventilatory practices is observed.

Regarding specialized ventilator ventilation, different ventilatory strategies are available for the clinician, however the scientific literature remains poor on this subject, especially in terms of safety and effectiveness of these strategies. Volume-assisted ventilation (VAC) is the most frequently used ventilatory strategy in the world, with the theoretical advantage of controlling the volume delivered to the patient, without being able to guarantee the pressures. Other alternative modes regulated in pressure exist but have the disadvantage of not guaranteeing volumes and minute ventilation. Each of these strategies (volume or pressure mode) is used in common practice, often with a preference for this or that ventilatory technique depending on the center and the available equipment.

The investigators therefore consider it important to accurately assess the ventilatory performance of these two strategies throughout CPR.

To do this, the investigators will conduct an observational, multicentre study. This study will aim to describe the ventilation patterns, describe the evolution of ventilation over time and finally to describe the safety data, for these two strategies during specialized cardiopulmonary resuscitation of pre-hospital cardiorespiratory arrest.

Keywords
CPR, Cardiopulmonary Arrest, Mechanical ventilation, Volume ventilation, Pressure ventilation
Medical subject headings
Heart Arrest

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of minute ventilation depending on capnogram analysis (CO2 patterns)

    Actual minute ventilation (L/min) associated with the predefined CO2 patterns, expressed in L/min/pattern

    Measured: 12 hours

Secondary outcomes (14)
  1. Description of ventilation

    • active ventilation expressed in percentage of minute ventilation
    • passive ventilation expressed in percentage of minute ventilation

    Measured: 12 hours

  2. Description of capnogram CO2 patterns

    Distribution of each predefined CO2 patterns expressed in percentage of capnograms recorded per patient.

    Measured: 12 hours

  3. Description of CPR quality in terms of chest compressions frequency

    Chest compressions frequency analysis will be expressed in time during which chest compression frequency (fCT) is within the predefined ranges (100 to 120 compressions/min) expressed in percentage.

    Measured: 12 hours

  4. Description of CPR quality in terms of time spent to continuous compressions

    CPR quality criteria analysis will be based in this analysis on CPR fraction (%CT), expressed in percentage, that expresses the percentage of time spent to continuous chest compressions over the total time of cardiopulmonary resuscitation.

    Measured: 12 hours

  5. Description of initial cardiac rhythm during CPR

    Cardiac rhythm will be expressed in percentage of the entire population

    Measured: 12 hours

  6. Description of return of spontaneous circulation (ROSC)

    Presence of return of spontaneous circulation (ROSC) will be expressed in percentage of the entire population

    Measured: 12 hours

  7. Survival at hospital arrival

    Survival at hospital arrival will be expressed in percentage of the entire population

    Measured: 12 hours

  8. Description of cardiac arrest etiologies characteristics

    Proportion of cardiac arrest etiologies will be expressed in percentages of the entire population

    Measured: 12 hours

  9. Description of presence of lay-rescuers CPR

    Proportion of presence of lay-rescuers will be expressed in percentages of the entire population

    Measured: 12 hours

  10. Description of initiation of CPR by-first aid

    Proportion of initiation of CPR first-aid will be expressed in percentages of the entire population

    Measured: 12 hours

  11. Description of use of automated chest compressions devices

    Proportion of use of automated chest compressions devices will be expressed in percentages of the entire population

    Measured: 12 hours

  12. Description of use of defibrillators

    Proportion of use of defibrillators will be expressed in percentages of the entire population

    Measured: 12 hours

  13. Description of use of Extra Corporeal cardio Pulmonary Resuscitation (ECPR)

    Proportion of use of Extra Corporeal cardio Pulmonary Resuscitation (ECPR) will be expressed in percentages of the entire population

    Measured: 12 hours

  14. Observation of ventilation major events

    Ventilation major events will be defined in percentage of the entire population:

    • Occurence of extubation expressed in percentage
    • Triggering of high pressure alarm expressed in percentage
    • Triggering of low volume (expired volume) alarm expressed in percentage
    • Occurence of hemoptysis in intubation sonde expressed in percentage
    • Occurence of pulmonary edema expressed in percentage

    Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2023
  2. Study start10 Dec 2023 (estimated)
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06175689
Sponsor's protocol ID
CPR CPV
Status last verified
Dec 2023
First submitted
9 Oct 2023
Last updated
19 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Perkins GD, Graesner JT, Semeraro F, Olasveengen T, Soar J, Lott C, Van de Voorde P, Madar J, Zideman D, Mentzelopoulos S, Bossaert L, Greif R, Monsieurs K, Svavarsdottir H, Nolan JP; European Resuscitation Council Guideline Collaborators. European Resuscitation Council Guidelines 2021: Executive summary. Resuscitation. 2021 Apr;161:1-60. doi: 10.1016/j.resuscitation.2021.02.003. Epub 2021 Mar 24.

    PubMed 33773824
  • Hubert H, Tazarourte K, Wiel E, Zitouni D, Vilhelm C, Escutnaire J, Cassan P, Gueugniaud PY; GR- ReAC. Rationale, methodology, implementation, and first results of the French out-of-hospital cardiac arrest registry. Prehosp Emerg Care. 2014 Oct-Dec;18(4):511-9. doi: 10.3109/10903127.2014.916024. Epub 2014 May 30.

    PubMed 24877567
  • Merchant RM, Topjian AA, Panchal AR, Cheng A, Aziz K, Berg KM, Lavonas EJ, Magid DJ; Adult Basic and Advanced Life Support, Pediatric Basic and Advanced Life Support, Neonatal Life Support, Resuscitation Education Science, and Systems of Care Writing Groups. Part 1: Executive Summary: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020 Oct 20;142(16_suppl_2):S337-S357. doi: 10.1161/CIR.0000000000000918. Epub 2020 Oct 21. No abstract available.

    PubMed 33081530
  • Considine J, Gazmuri RJ, Perkins GD, Kudenchuk PJ, Olasveengen TM, Vaillancourt C, Nishiyama C, Hatanaka T, Mancini ME, Chung SP, Escalante-Kanashiro R, Morley P. Chest compression components (rate, depth, chest wall recoil and leaning): A scoping review. Resuscitation. 2020 Jan 1;146:188-202. doi: 10.1016/j.resuscitation.2019.08.042. Epub 2019 Sep 16.

    PubMed 31536776
  • Stiell IG, Brown SP, Nichol G, Cheskes S, Vaillancourt C, Callaway CW, Morrison LJ, Christenson J, Aufderheide TP, Davis DP, Free C, Hostler D, Stouffer JA, Idris AH; Resuscitation Outcomes Consortium Investigators. What is the optimal chest compression depth during out-of-hospital cardiac arrest resuscitation of adult patients? Circulation. 2014 Nov 25;130(22):1962-70. doi: 10.1161/CIRCULATIONAHA.114.008671. Epub 2014 Sep 24.

    PubMed 25252721
  • Stiell IG, Brown SP, Christenson J, Cheskes S, Nichol G, Powell J, Bigham B, Morrison LJ, Larsen J, Hess E, Vaillancourt C, Davis DP, Callaway CW; Resuscitation Outcomes Consortium (ROC) Investigators. What is the role of chest compression depth during out-of-hospital cardiac arrest resuscitation? Crit Care Med. 2012 Apr;40(4):1192-8. doi: 10.1097/CCM.0b013e31823bc8bb.

    PubMed 22202708
  • Edelson DP, Abella BS, Kramer-Johansen J, Wik L, Myklebust H, Barry AM, Merchant RM, Hoek TL, Steen PA, Becker LB. Effects of compression depth and pre-shock pauses predict defibrillation failure during cardiac arrest. Resuscitation. 2006 Nov;71(2):137-45. doi: 10.1016/j.resuscitation.2006.04.008. Epub 2006 Sep 18.

    PubMed 16982127
  • Babbs CF, Kemeny AE, Quan W, Freeman G. A new paradigm for human resuscitation research using intelligent devices. Resuscitation. 2008 Jun;77(3):306-15. doi: 10.1016/j.resuscitation.2007.12.018. Epub 2008 Mar 7.

    PubMed 18329159
  • Henlin T, Michalek P, Tyll T, Hinds JD, Dobias M. Oxygenation, ventilation, and airway management in out-of-hospital cardiac arrest: a review. Biomed Res Int. 2014;2014:376871. doi: 10.1155/2014/376871. Epub 2014 Mar 3.

    PubMed 24724081
  • Vissers G, Soar J, Monsieurs KG. Ventilation rate in adults with a tracheal tube during cardiopulmonary resuscitation: A systematic review. Resuscitation. 2017 Oct;119:5-12. doi: 10.1016/j.resuscitation.2017.07.018. Epub 2017 Jul 21.

    PubMed 28739281
  • Cordioli RL, Grieco DL, Charbonney E, Richard JC, Savary D. New physiological insights in ventilation during cardiopulmonary resuscitation. Curr Opin Crit Care. 2019 Feb;25(1):37-44. doi: 10.1097/MCC.0000000000000573.

    PubMed 30531537
  • Cordioli RL, Brochard L, Suppan L, Lyazidi A, Templier F, Khoury A, Delisle S, Savary D, Richard JC. How Ventilation Is Delivered During Cardiopulmonary Resuscitation: An International Survey. Respir Care. 2018 Oct;63(10):1293-1301. doi: 10.4187/respcare.05964. Epub 2018 May 8.

    PubMed 29739857

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiopulmonary Arrest and Mechanical Ventilation Complication, run by University Hospital, Angers.

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 5 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Francois Morin, MD, MSc (0666431611, francois.morin@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of minute ventilation depending on capnogram analysis (CO2 patterns) (time frame: 12 hours). 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 NCT06175689, which also lists 12 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 19 Dec 2023.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in