Ventilation quality feedback devices: BLS TF 2402 ScR

Conflict of Interest Declaration

The ILCOR Continuous Evidence Evaluation process is guided by a rigorous ILCOR Conflict of Interest policy. The following Task Force members and other authors were recused from the discussion as they declared a conflict of interest: None

The following Task Force members and other authors declared an intellectual conflict of interest and this was acknowledged and managed by the Task Force Chairs and Conflict of Interest committees:

• Guillaume Debaty received funding from the University of Grenoble Alps for studies on cadavers examining ventilation during CPR.
• Nick Johnson: Funding from the American Heart Association for a study examining ventilation during CPR.

Task Force Synthesis Citation

Debaty G, Johnson NJ, Dewan M, Morrison LJ, Bray J - on behalf of the International Liaison Committee on Resuscitation Basic Life Support Task Force. Ventilation quality feedback devices: a scoping review: International Liaison Committee on Resuscitation (ILCOR) Basic Life Support Task Force, 2024 Nov 5. Available from: http://ilcor.org

Methodological Preamble and Link to Published Scoping Review

The continuous evidence evaluation process started with a scoping review conducted by the ILCOR BLS Task Force Scoping Review team. Evidence for adult and pediatric literature was sought and considered by the Basic Life Support Adult Task Force and the Pediatric Task Force groups respectively.

Debaty G, Johnson NJ, Dewan M, Morrison LJ, Bray - on behalf of the International Liaison Committee on Resuscitation Basic Life Support Task Force. Ventilation quality feedback devices: a scoping review. In draft

PICOST

The PICOST (Population, Intervention, Comparator, Outcome, Study Designs and Timeframe)

Population: Adults and children in any setting (out-of-hospital or in-hospital) in cardiac arrest.

Intervention: Real-time ventilation quality feedback (e.g. tidal volume, adequate ventilation, mask leak, ventilation rate).

Comparators: No real-time ventilation feedback

Outcomes: Any outcome with a preference for outcomes listed in the ILCOR COSCA or P-COSCA. .(Topjian 2020, e246)

Study Designs: Randomized controlled trials (RCTs) and non-randomized studies (non-randomized controlled trials, interrupted time series, controlled before-and-after studies, cohort studies), simulation studies, case series, and case reports are eligible for inclusion. Grey literature (Google Scholar - first 20 pages), letters to the Editor and conference abstracts are also eligible for inclusion.

All relevant publications in any language are included as long as there is an English abstract.

Timeframe: Databases searched from inception to September 11, 2024. Grey literature searched November 4th 2024.

Search Strategies

Articles for review were obtained by searching PubMed, EMBASE, Cochrane for all entries from database inception to September 11, 2024.

Keywords included in the search were: Respiration, Artificial/ Ventilation/ Pulmonary Ventilation/ Intubation, Intratracheal / ventilation / bag valve* or self-inflating bag / respiratory rate / Tidal Volume/ Feedback / audio or audiovisual or visual / feedback or feed-back / real-time or real-time / feedback device

Inclusion and Exclusion criteria

To be included, studies needed to assess a device to deliver real-time ventilation quality feedback (e.g. tidal volume, adequate ventilation, mask leak, ventilation rate). Simulation and cadaver studies assessing ventilation using ventilation quality feedback devices were included. Publications in any language were included if an English abstract was available.

Studies were excluded if they: included devices with only prompts to help guide ventilation rates (metronome, flashing lights); related to devices that need an advanced airway (e.g. endotracheal tube, supraglottic airway) and/or design to actively improve the performance of ventilation (mechanical ventilators, devices design to improve circulation…); or, included only ventilation feedback built into a training manikin or audio/visual feedback provided by an instructor.

Data tables

See table 1. BLS 2402 Ventilation feeback devices Scr data tables

Task Force Insights

1. Why this topic was reviewed.

The BLS Task Force chose to review this specific topic because new devices are now available to monitor and improve real-time ventilation for basic life support providers, these devices and the ventilation outcomes they measure were not covered in our recent review²⁰ and there is no specific existing treatment recommendation.

Current guidelines recommend delivering 8–12 ventilations per minute with a tidal volume (Vt) of 500–600 mL.^2,22 However, most clinical studies on real-time CPR feedback have primarily focused on ventilation rates rather than the quality or adequacy of ventilations.^1,3 Advances in technology now enable the measurement of both ventilation rate and insufflation volume. Alarmingly, a recent study reported inadequate ventilation delivery in over 60% of CPR pauses during out-of-hospital cardiac arrests, which was associated with decreased rates of return of spontaneous circulation (ROSC), survival, and favorable neurological outcomes.¹¹ Given these findings, the Basic Life Support (BLS) task force prioritized this topic, initiating a scoping review to: (1) examine whether ventilation feedback devices improve patient and ventilation outcomes and (2) assess the quality and performance of these devices.

2. Narrative summary of evidence identified

In our search of 769 titles and abstracts, we identified 19 studies (14 full articles and 5 conference abstracts) relevant to the PICOST question. The included studies consisted of one randomized trial,¹⁴ two before-after prospective studies,^1,7 two observational studies,^15,18 one case series including three patients⁸ and 13 simulation studies.^{4-6,9,10,12,13,16,17,19,21,23,24} Only three simulation studies assessed pediatric scenarios.^10,16,23 The attached data table presents a summary of the main settings and findings.

Clinical outcomes

We identified one single-center RCT¹⁴ and two prospective observational studies reporting clinical outcomes^1,7:

• In the RCT, ¹⁴ adult patients (n=121) were randomized to either real-time visual ventilation feedback using a pressure-flow sensor or no audio-visual ventilation feedback. No differences between groups were reported for rates of survival to discharge or rates of survival with good neurological outcome. A significant increase was seen for ROSC (55.5% vs. 36.2%, p=0.04) and 30-hour survival (49.2% vs. 46.5%, p=0.001) with audio-visual ventilation feedback. The study reported no data on ventilation quality, and the data was not adjusted for differences reported between the groups (e.g. more cardiac arrests occurred in public in the feedback group).
• A prospective before-after clinical study¹ included 156 adult patients (101 in the ventilation feedback group and examined the introduction of a real-time feedback device assessing ventilation rate by thoracic impedance. This study showed no difference in unadjusted ROSC (40.0% versus 44.6%, p=0.58) or survival to hospital discharge between groups (9.1% versus 8.9%, p=0.97).
• A prospective before-after clinical study⁷ included 412 adult patients (221 in the ventilation feedback group) and examined the introduction of a visual real-time ventilation feedback device using a pressure-flow sensor. This study showed no difference in unadjusted ROSC (27% vs. 29%, p=NS) between groups. An adjusted exploratory analysis showed neither ventilation rate (OR 1.11, 95%CI 0.99 to 1.26, p=0.08) or insufflation volume OR 1.07, 95%CI:0.93 to 1.25, p=0.35) were associated with ROSC.

Ventilation outcomes

• Ventilation rate

We identified one clinical study¹ and one simulation study⁹ with a feedback device assessing only the ventilation rate. Abella et al. observed a small improvement in the ventilation rate variability with the use of a visual feedback device using thoracic impedance (20+/-10 vs. 18+/-8 ventilation per min, p=0.12 for difference in mean and p=0.04 for difference in variance)¹.

One simulation study, published as a conference abstract, observed a significant improvement in ventilation rates using a real-time ventilation timer. They observed a decrease in hyperventilation in the feedback group [13.04 breaths/min (95%CI: 9.29 to 16.78) vs. 11.77 breaths/min (95%CI: 8.02 to 15.51), p=0.016]¹⁹.

• Ventilation rate and insufflation volume

Drennan et al⁷ observed an improvement in almost all ventilation parameters assessed with the use of real-time ventilation feedback measuring insufflation volume. Ventilation rate decreased from 14 (IQR 11, 19) to 12 (IQR 10, 17) (p=0.04). When examined by the proportion within the targeted range, improvements were seen for ventilation rate (53%±38 vs. 29%±9, p<0.001), insufflation volume (28%±17 vs. 21%±16, p<0.001) and insufflation volume and rate combined (19%±17 vs. 7%±10, p<0.001).

The three other observational studies examined these outcomes to assess insufflation volume and ventilation rate delivered during CPR. When blinded to the feedback device, rate and insufflation volume measured exceeded guideline recommended ventilation parameters.^15,18 One study, comparing insufflation volume delivered by EMS providers to hospital staff immediately after ED admission observed significant variation in volume and rate delivered (volume and rate delivered by hospital staff exceeded EMS providers in all 3 cases reported).⁸

Twelve simulation studies assessed a visual feedback device using a flow, and/or pressure-based flow sensor technology assessed insufflation volume and ventilation rate during CPR^{4-6,9,10,12,13,16,17,21,23,24}:

• In eleven simulation studies, visual real-time feedback was compared to no feedback.^{4,6,9,10,12,13,17,19,21,23,24} A significant improvement in insufflation volume was reported in all studies. Ventilation rates were significantly improved and higher compliant with current guidelines was reported in 5 of 9 studies with a reported rate.^{4,9,10,12,13,17,19,21,24}
• One simulation study observed, when providers were blinded to the feedback device, a significant variation in insufflation volume measured according to sex of the provider (587±168 for female vs. 685±134 for male, p=0.05) or their glove size (618±114 for small, 566±181 for medium and 728±153 for large, p=0.027).²¹
• One simulation study compared visual feedback device use with rate and insufflated volume visually assessed by trained instructors. Instructors seemed to overestimate significantly the compliance with guidelines for rate and volume delivered by students⁵.
• Only three studies assessed pediatric bag valve ventilation in manikins.^10,16,23 Heo et al observed a significant improvement in the proportion of adequate insufflation volume measured (IV) and ventilation intervals (VI) with real-time feedback (IV:89.51% vs. 72.66%, VI: 95.83% vs. 57.14%, all p values<0.001).¹⁰ Lemoine et al assessed in a simulated 3-years old manikin setting, the performance of BLS providers to perform adequate ventilation. They observed a low proportion (13%) of ventilation in target volume.¹⁶ Wagner et al observed a decrease in insufflation volume measured (10.15±4.6 vs. 12.83±6.0, p=0.002) and a decrease in mask leak (24.10%±18.6 vs. 31.76%±23.4, p=0.009) using ventilation feedback. They also observed that Participants’ subjective workload rating increased by 3.5% (p=0.018) and 8% (p<0.001) when provided with feedback.²³

3. Narrative Reporting of the task force discussions

The BLS Task Force considered the following discussion points:

• While there is a growing body of published research in this area, there is a need for more clinical evidence before progression to a formal systematic review.
• Seven of 19 studies were either sponsored or performed directly by industry. Independent research should be encouraged on the topic.
• The definition of ventilation parameters assessed by the devices needs to be standardized. Many of the identified studies incorrectly labelled the amount of airflow measured at the mask or the advanced airway as tidal volume. We suggest avoiding using the term tidal volume for this measurement since tidal volume represents the amount of air that moves in or out of the lungs with each respiratory cycle. This parameter is not directly measured in any of the published studies, with the devices used in most included studies measuring the insufflation volume as it passes into the mask or the advanced airway. In one study,¹ chest wall impedance was measured which indirectly measures lung expansion. In one clinical study ¹⁵ and two simulation studies ^16,23 the volume exhaled was measured in addition as it passed between the airway or mask through the device. We acknowledge that the current development of real-time ventilation feedback devices offers a unique opportunity to measure the ventilation rate and the insufflation volume measured before the mask or the advanced airway during CPR. Whether doing so indirectly measures the quality of ventilation delivered during CPR or improves outcomes remains unknown.
• We acknowledge that differences in ventilation delivered during CPR might be related to the training, sex, and size of the rescuers^5,21. These devices could provide a means to achieve objective measurement, standardize training, and limit individual variations during CPR.
• Device registration with regulatory authorities alone does not provide evidence of device performance in real-world settings. As rescuer and patient factors influence high-quality ventilation delivery, further research is required to demonstrate the role and clinical efficacy of real-time ventilation feedback devices.
• This scoping review has not identified sufficient new evidence to prompt a new systematic review or a specific good practice statement for ventilation feedback devices.

Knowledge Gaps

We found scant evidence on the effect of real-time ventilation feedback devices on clinical outcomes. Clinical evaluation of the clinical effectiveness of real-time ventilation feedback devices is needed.

Other gaps in the evidence for real-time ventilation feedback devices include:

• The ideal targets or goals for ventilation during CPR have not been clearly elucidated, and current guidelines are based on low-quality evidence.
• The performance of the different devices has not been assessed in clinical data compared to validated measurements. In particular, measuring true tidal and exhaled volumes (to assess leak) can be difficult to validate during CPR.
• The lack of evidence of clinical efficacy (i.e. whether the devices work in optimal settings) or clinical effectiveness (real-world settings).

References

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2. Berg KM, Soar J, Andersen LW, Bottiger BW, Cacciola S, Callaway CW, Couper K, Cronberg T, D'Arrigo S, Deakin CD, et al. Adult Advanced Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020;142:S92-S139. doi: 10.1161/CIR.0000000000000893

3. Bobrow BJ, Vadeboncoeur TF, Stolz U, Silver AE, Tobin JM, Crawford SA, Mason TK, Schirmer J, Smith GA, Spaite DW. The influence of scenario-based training and real-time audiovisual feedback on out-of-hospital cardiopulmonary resuscitation quality and survival from out-of-hospital cardiac arrest. Ann Emerg Med. 2013;62:47-56.e41. doi: 10.1016/j.annemergmed.2012.12.020

4. Charlton K, McClelland G, Millican K, Haworth D, Aitken-Fell P, Norton M. The impact of introducing real time feedback on ventilation rate and tidal volume by ambulance clinicians in the North East in cardiac arrest simulations. Resusc Plus. 2021;6:100130. doi: 10.1016/j.resplu.2021.100130

5. D'Agostino F, Agro FE, Petrosino P, Ferri C, Ristagno G. Are instructors correctly gauging ventilation competence acquired by course attendees? Resuscitation. 2024;200:110240. doi: https://dx.doi.org/10.1016/j.resuscitation.2024.110240

6. Dinh AT, Eyer X, Chauvin A, Outrey J, Vivien B, Khoury A, Plaisance P. Evaluation of EOlifeX®, a Ventilation Feedback Device during cardiopulmonary resuscitation in medical students training. Resuscitation. 2023;192. doi: 10.1016/s0300-9572(23)00447-1

7. Drennan IR, Lee M, Héroux J-P, Lee A, Riches J, Peppler J, Poitras A, Cheskes S. The impact of real-time feedback on ventilation quality during out-of-hospital cardiac arrest: A before-and-after study. Resuscitation. 2024;204. doi: 10.1016/j.resuscitation.2024.110381

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10. Heo S, Yoon SY, Kim J, Kim HS, Kim K, Yoon H, Hwang SY, Cha WC, Kim T. Effectiveness of a Real-Time Ventilation Feedback Device for Guiding Adequate Minute Ventilation: A Manikin Simulation Study. Medicina (Kaunas). 2020;56. doi: 10.3390/medicina56060278

11. Idris AH, Aramendi Ecenarro E, Leroux B, Jaureguibeitia X, Yang BY, Shaver S, Chang MP, Rea T, Kudenchuk P, Christenson J, et al. Bag-Valve-Mask Ventilation and Survival From Out-of-Hospital Cardiac Arrest: A Multicenter Study. Circulation. 2023;148:1847-1856. doi: 10.1161/circulationaha.123.065561

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13. Kim JW, Park SO, Lee KR, Hong DY, Baek KJ. Efficacy of Amflow®, a Real-Time-Portable Feedback Device for Delivering Appropriate Ventilation in Critically Ill Patients: A Randomised, Controlled, Cross-Over Simulation Study. Emerg Med Int. 2020;2020:5296519. doi: 10.1155/2020/5296519

14. Lee ED, Jang YD, Kang JH, Seo YS, Yoon YS, Kim YW, Jeong WB, Ji JG. Effect of a Real-Time Audio Ventilation Feedback Device on the Survival Rate and Outcomes of Patients with Out-of-Hospital Cardiac Arrest: A Prospective Randomized Controlled Study. J Clin Med. 2023;12. doi: 10.3390/jcm12186023

15. Lemoine F, Jost D, Tassart B, Petermann A, Lemoine S, Salome M, Frattini B, Travers S. 464 Evaluation of ventilation quality by basic life support teams during out-of-hospital cardiac arrest : preliminary results from a prospective observational study - the vecars study. Resuscitation. 2024;203:S215. doi: 10.1016/S0300-9572(24)00746-9

16. Lemoine S, Jost D, Petermann A, Salome M, Tassart B, Lemoine F, Briche F, Liscia J, Bon O, Travers S. 411 compliance with pediatric manual ventilation guidelines by professional basic life support rescuers during out-of-hospital cardiac arrest: a simulation study. Resuscitation. 2024;203:S192. doi: 10.1016/S0300-9572(24)00701-9

17. Lyngby RM, Clark L, Kjoelbye JS, Oelrich RM, Silver A, Christensen HC, Barfod C, Lippert F, Nikoletou D, Quinn T, et al. Higher resuscitation guideline adherence in paramedics with use of real-time ventilation feedback during simulated out-of-hospital cardiac arrest: A randomised controlled trial. Resusc Plus. 2021;5:100082. doi: 10.1016/j.resplu.2021.100082

18. McCarty K, Roosa J, Kitamura B, Page R, Roque P, Silver A, Spaite D, Stolz U, Vadeboncoeur T, Bobrow B. Ventilation rates and tidal volume during emergency department cardiac resuscitation. Resuscitation. 2012;83. doi: 10.1016/j.resuscitation.2012.08.114

19. Melia MR, Handbury JD, Janney J. Evaluation of ventilatory rates and the benefits of an immediate feedback device with and without supplementary instruction on out-of-hospital resuscitations. Academic Emergency Medicine. 2012;19:S261. doi: https://dx.doi.org/10.1111/j.1553-2712.2012.01332.x

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21. Scott JB, Schneider JM, Schneider K, Li J. An evaluation of manual tidal volume and respiratory rate delivery during simulated resuscitation. Am J Emerg Med. 2021;45:446-450. doi: 10.1016/j.ajem.2020.09.091

22. Soar J, Bottiger BW, Carli P, Couper K, Deakin CD, Djarv T, Lott C, Olasveengen T, Paal P, Pellis T, et al. European Resuscitation Council Guidelines 2021: Adult advanced life support. Resuscitation. 2021;161:115-151. doi: 10.1016/j.resuscitation.2021.02.010

23. Wagner M, Gröpel P, Eibensteiner F, Kessler L, Bibl K, Gross IT, Berger A, Cardona FS. Visual attention during pediatric resuscitation with feedback devices: a randomized simulation study. Pediatr Res. 2022;91:1762-1768. doi: 10.1038/s41390-021-01653-w

24. You KM, Lee C, Kwon WY, Lee JC, Suh GJ, Kim KS, Park MJ, Kim S. Real-time tidal volume feedback guides optimal ventilation during simulated CPR. Am J Emerg Med. 2017;35:292-298. doi: 10.1016/j.ajem.2016.10.085