Evaluating the Performance of Invasive Ventilation During Specialized CPR
NCT ID: NCT06175689
Last Updated: 2023-12-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Total Enrollment
400 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-12-10
Study Completion Date
2025-01-01
Brief Summary
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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.
Detailed Description
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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.
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.
Conditions
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Cardiopulmonary Arrest
Mechanical Ventilation Complication
Keywords
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CPR
Cardiopulmonary Arrest
Mechanical ventilation
Volume ventilation
Pressure ventilation
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Grenoble
OTHER
Sponsor Role
collaborator
Hôpital Necker-Enfants Malades
OTHER
Sponsor Role
collaborator
Centre Hospitalier Annecy Genevois
OTHER
Sponsor Role
collaborator
University Hospital, Angers
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Central Contacts
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References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
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CPR CPV
Identifier Type: -
Identifier Source: org_study_id