Comparison of the MultiViewScope Stylet Scope and the direct laryngoscope with the Miller blade for the intubation in normal and difficult pediatric airways: A randomized, crossover, manikin study

Kohei Godai; Takahiro Moriyama; Yuichi Kanmura

doi:10.1371/journal.pone.0237593

Peer Review History

Original SubmissionJune 10, 2020
15 Jul 2020 Decision Letter - Georg M. Schmölzer, Editor PONE-D-20-17747 Comparison of the MultiViewScope Stylet Scope and the direct laryngoscope with the Miller blade for the intubation in normal and difficult pediatric airways: a randomized, crossover, manikin study PLOS ONE Dear Dr. Kohei Godai, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by August 31 2020. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Dear Authors, Thank you very much for going through the trouble of doing research in the field of pediatric airway management. Manikin trials are mandatroy to evalaute new devices and new techniques for airway management but have their own limitations. I appreaciated that the authors mentioned some of these limitations in their discussion section of the manuscript. However, I was wondering what these data actually mean for the anesthesiologist? What are next meaningful steps to further evaluate the MultiViewScope? I suggest to include some information in the manuscript (discussion section) what these data mean and what the next steps could be. Specidfic Comments: 1.) The MultiViewScope Stylet is not a comonly used device in the word. I suggest to include a picture in the manuscript and elaborate a little more the build of the design. This would help the readers that are not familiar with the device. 2.) Abstract, concusions: Please include information what the presented data actually mean. What is the concusion after performing this trial and presenting the data? The current version of the conclsion is a very short result summary. 3.) Introduction: ... pediatric airway is challenging... What makes the pediatric airway challenging? Please be more spcific in this section. Is it an anatmically challenging airway (Is it the visulization of the glottis? Tube positioning?)? Or a physilogically difficult airway (risk of hypoxia)? Or both? 4.) What age does the infant manikin mimiking Pierre Robin syndrome represent? Could it be a problem that potentiallt two different ages are used for this trial? Please comment. 5.) I am not sure if I understood the randomization process correctly. Why was the "normal" airway intubated first, followed by the Pierre Robing manikin? Where is the randomization with this approach? 6.) Data is reported as median? Statistics is reported as means? This seems confisuing, could you please report median with corresponding tests or means with the approbiate tests? 7.) Looking at Cormack and Lehane gradring and intubation times it seems that the difficult airway might not have been difficult. Could this have influenced the data presented? Please comment. 8.) Cormack Lehane grading looks VERY similar CL1 (1 to 1) vs CL2 (1 to 2) between devices in difficult airway scenario. Not sure how the p <0.001 fits to this? Is a CL1 vs CL2 clinically relevant? 9.) Discussion line 216 - 218. How can the MVS provide a better view then the Bonfils? Is there a published trial to support this? Most trials with the Bonfils describe a CL1 view (which is needed to advance the tube). Please check and comment. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). 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Revision 1
19 Jul 2020 Author Response Georg M. Schmölzer, M.D., Ph.D. Academic Editor PLOS ONE 19 July 2020 Dear Dr. Schmölzer, Response to review of PONE-D-20-17747: Comparison of the MultiViewScope Stylet Scope and the direct laryngoscope with the Miller blade for the intubation in normal and difficult pediatric airways: a randomized, crossover, manikin study. We would like to thank the reviewer for the comments and for the help in improving the quality and clarity of our manuscript. Below are our point-by-point responses to their questions and suggestions. We hope that our manuscript is now suitable for publication in PLOS ONE. Reviewer's report: Reviewer #1 General: Thank you very much for going through the trouble of doing research in the field of pediatric airway management. Manikin trials are mandatroy to evalaute new devices and new techniques for airway management but have their own limitations. I appreaciated that the authors mentioned some of these limitations in their discussion section of the manuscript. However, I was wondering what these data actually mean for the anesthesiologist? What are next meaningful steps to further evaluate the MultiViewScope? I suggest to include some information in the manuscript (discussion section) what these data mean and what the next steps could be. Answer, as reviewer #1 suggested we include the information in the abstract and discussion. Page 3, line 40: The results of this study mean that the MVS Stylet Scope may be a less invasive airway devise than the direct laryngoscope with the Miller blade in the pediatric airway management. For the next step, we need to evaluate the MVS Stylet Scope in the real patients as an observational study. Page 25, line265: The results of this study mean that the MVS Stylet Scope may be a less invasive airway devise than the direct laryngoscope with the Miller blade in the pediatric airway management. For the next step, we need to evaluate the MVS Stylet Scope in the real patients as an observational study. ------------------------------------------------------------------------------- Major Compulsory Revisions (that the author must respond to before a decision on publication can be reached): 1.) The MultiViewScope Stylet is not a comonly used device in the word. I suggest to include a picture in the manuscript and elaborate a little more the build of the design. This would help the readers that are not familiar with the device. Response: as the reviewer #1 suggested we include the picture. Page 7, line 92: Fig 1. The MVS Stylet Scope. 2.) Abstract, concusions: Please include information what the presented data actually mean. What is the concusion after performing this trial and presenting the data? The current version of the conclsion is a very short result summary. Answer, as reviewer #1 suggested we include the information in the abstract and discussion. Page 3, line 40: The results of this study mean that the MVS Stylet Scope may be a less invasive airway devise than the direct laryngoscope with the Miller blade in the pediatric airway management. For the next step, we need to evaluate the MVS Stylet Scope in the real patients as an observational study. Page 25, line265: The results of this study mean that the MVS Stylet Scope may be a less invasive airway devise than the direct laryngoscope with the Miller blade in the pediatric airway management. For the next step, we need to evaluate the MVS Stylet Scope in the real patients as an observational study. 3.) Introduction: ... pediatric airway is challenging... What makes the pediatric airway challenging? Please be more spcific in this section. Is it an anatmically challenging airway (Is it the visulization of the glottis? Tube positioning?)? Or a physilogically difficult airway (risk of hypoxia)? Or both? Answer, we added the sentence in the introduction. Page 4, line 47: because of the following physiological features 4.) What age does the infant manikin mimiking Pierre Robin syndrome represent? Could it be a problem that potentiallt two different ages are used for this trial? Please comment. Answer, the age of the Pierre Robin manikin is a 3–6-month. Page 7, line 86: A 3–6-month 5.) I am not sure if I understood the randomization process correctly. Why was the "normal" airway intubated first, followed by the Pierre Robing manikin? Where is the randomization with this approach? Answer, as the reviewer #1 suggested, we added the reason. Page 7, line 112: We did not randomize the order of manikins, because we compared the devices not the manikins. Page 25, line 257: Another limitation of this study was that we did not randomize the order of manikins. This may account for our result that the time of successful intubation in the difficult pediatric airway was short compared to the normal pediatric airway in the anesthesiolosy residents. 6.) Data is reported as median? Statistics is reported as means? This seems confisuing, could you please report median with corresponding tests or means with the approbiate tests? Answer, as the reviewer #1 suggested, we added the explanations. Page 9, line 137: Normally distributed data are shown in means and standard deviations (SD). Data, which were not normally distributed, are shown in medians and interpercentile ranges (IQR). 7.) Looking at Cormack and Lehane gradring and intubation times it seems that the difficult airway might not have been difficult. Could this have influenced the data presented? Please comment. Answer, we believe that the small difference between the two manikins is due to the learning effects. Page 24, line 239: It is noteworthy that the times of successful intubation and Cormack–Lehane scale are similar in the two manikins. The mean time of successful intubation in the difficult pediatric airway was 28.4 sec, which was shorter than that of the normal pediatric airway (30.7 sec) in the anesthesiology residents. This may be due to the learning effects, because the mean time of successful intubation in the difficult pediatric airway (28.0 sec) was longer than that of the normal pediatric airway (24.3 sec) in the experienced expert anesthesiologists. Hippard et al. have reported that the time to intubation in the difficult pediatric airway manikin was shorter than the normal pediatric airway manikins [20]. We do not consider the learning effects have influenced our results, because we compared the devises, not the manikins. 8.) Cormack Lehane grading looks VERY similar CL1 (1 to 1) vs CL2 (1 to 2) between devices in difficult airway scenario. Not sure how the p <0.001 fits to this? Is a CL1 vs CL2 clinically relevant? Answer, since this study was a crossover study, the paired analysis was done. The paired analysis can detect small differences. Page 22, line 212: Although the differences of Cormack–Lehane scale between the MVS Stylet Scope and the direct laryngoscope using Miller #1 blade were small, we consider the differences are clinically significant. The reason is that the participants in the both groups reported improved difficulty of intubation with the MVS Stylet Scope. 9.) Discussion line 216 - 218. How can the MVS provide a better view then the Bonfils? Is there a published trial to support this? Most trials with the Bonfils describe a CL1 view (which is needed to advance the tube). Please check and comment. Response: as the reviewer #1 suggested, we deleted the sentence. Page 23, line 231: Because of the difference in the tip, The MVS Stylet Scope might provide better view of vocal cords than Bonfils retromolar intubation fiberscope. ------------------------------------------------------------------------------- Minor Essential Revisions (such as missing labels on figures, or the wrong use of a term, which the author can be trusted to correct): None ------------------------------------------------------------------------------- Discretionary Revisions (which the author can choose to ignore): None ------------------------------------------------------------------------------- Sincerely yours, Kohei Godai, M.D., Ph.D. Department of Anesthesiology and Critical Care Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan Tel: +81-99-275-5430; Fax: +81-99-265-1642 E-mail: kxg179@icloud.com https://doi.org/10.1371/journal.pone.0237593.r002
30 Jul 2020 Decision Letter - Georg M. Schmölzer, Editor Comparison of the MultiViewScope Stylet Scope and the direct laryngoscope with the Miller blade for the intubation in normal and difficult pediatric airways: a randomized, crossover, manikin study PONE-D-20-17747R1 Dear Dr. Godai, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Georg M. Schmölzer Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0237593.r003
Formally Accepted
5 Aug 2020 Acceptance Letter - Georg M. Schmölzer, Editor PONE-D-20-17747R1 Comparison of the MultiViewScope Stylet Scope and the direct laryngoscope with the Miller blade for the intubation in normal and difficult pediatric airways: a randomized, crossover, manikin study Dear Dr. Godai: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Georg M. Schmölzer Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0237593.r004

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