Prospective comparative analysis of noninvasive body temperature monitoring using zero heat flux technology (SpotOn sensor) compared with esophageal temperature monitoring during pediatric surgery

Bo-Hyun Sang; Changjin Lee; Da Yeong Lee

doi:10.1371/journal.pone.0272720

Peer Review History

Original SubmissionJune 15, 2022
6 Jul 2022 Decision Letter - William M. Adams, Editor PONE-D-22-17177Prospective comparative analysis of noninvasive body temperature monitoring using zero heat flux technology (SpotOn sensor) compared with esophageal temperature monitoring during pediatric surgeryPLOS ONE Dear Dr. Sang, 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. ============================== ACADEMIC EDITOR: The reviewers have highlighted a few items that must be addressed within the revised version of the manuscript.============================== Please submit your revised manuscript by Aug 20 2022 11:59PM. 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. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, William M. Adams Academic Editor PLOS ONE Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. Additional Editor Comments: The submitted manuscript is well executed and will contribute to the body of knowledge. Please address the points outlined by the reviewers in your revision. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? 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: Partly Reviewer #2: Yes Reviewer #3: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: I Don't Know ****** 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 Reviewer #2: Yes Reviewer #3: 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 Reviewer #2: Yes Reviewer #3: 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: I would like to thank the editor for the opportunity to review the manuscript entitled "Prospective comparative analysis of noninvasive body temperature monitoring using zero heat flux technology (SpotOn sensor) compared with esophageal temperature monitoring during pediatric surgery". The paper is well-written and the study has been well designed and described. Monitoring body temperature in the clinical setting is of great importance and one of the greatest challenge is represented by the need to measure or estimate core body temperature values with as less invasive as possible techniques due to several limitation that can depend on the setting or patient. This study provides a comparison between a non-invasive device (SpotOn) based on the ZHF technology, and a standard-use technology in ICU or surgery, as the esophageal temperature, in a specific population, i.e., pediatric surgery patients. The results suggest a good agreement between the techniques, but some limitations can be also considered as the time needed to reach good agreement values, and some poor readings when temperature is < 36.5 Based on these considerations, the manuscript is worth of publication; however, I have few suggestions I would like to make before acceptance. In general, I suggest to expand the references a little bit, by adding some papers and reviews on this topic. - Introduction: Correctly the authors state that few studies are present about the validation of ZHF in pediatric patients (lines 73-74). Can the authors cite here some of the papers that are already present in the literature, or some reviews? (e.g., Lee et al., 2021; Nemeth et al., 2020, Carvalho et al., 2019; Morettini et al., 2020; Conway et al., 2021). - Results: Results are well presented, although since the authors present the "temperature zones" analysis, it might be interesting to know how many readings were found in each zone for the esophageal probe. Indeed, since it is reported the lower agreements are present when temperature is < 36.5 °C, it might be important to understand how much common such zone can be during such surgery in pediatric patients. - Discussion: Based on these findings, I would suggest to well highlight the limitations about the validity of the ZHF system (i.e., time after induction + low body temperature), and maybe provide some sort of recommendations for its use (e.g., to wait n minutes before considering the measurement correct, or to be careful when <36.5 °C is expected). Reviewer #2: In the present study, the authors sought to validate the non-invasive “SpotOn” measurement technic for estimating core temperature against esophageal temperature in children undergoing surgery. The authors found exceptionally good agreement of the SpotOn method. My only comment is that I wish the authors had also compared to other acceptable non-invasive methods for measuring core temperature, such as surface temperature over the carotid (Jay et al, 2013, Pediatric Anesthesia; Imani et al, 2016, Anesthesiology and pain medicine). The authors should mention this technic in their intro and discussion, however, SpotOn had better agreement in this study than surface carotid temperature in those other studies, and therefore mentioning these studies should only serve to strengthen the argument for this new technic. Minor comments below. Great job! P3, L28 – Missing space after period P3, L30 – Missing space after period P3, L37 – This should be -0.07, shouldn’t it? P6, L108 – Double ref 10 Reviewer #3: The current manuscript compares the SpotOn sensor to esophageal and axillary temperatures during elective pediatric surgery. Collectively, I have little issues with the manuscript and the statistical analysis done. In my opinion, the purpose of the study has been justified and well executed. However, the main concern I have with the findings is the weaker relationship between esophageal temperature and the SpotOn sensor at lower internal temperatures (<36.5C). In my opinion, this should be more thoroughly highlighted in the discussion, especially when the authors allude to emergency patients (whom still need to be investigated) having greater vulnerability to impaired thermoregulatory control. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No Reviewer #3: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0272720.r001
Revision 1
22 Jul 2022 Author Response EDITOR’S COMMENTS: Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Thank you for your comment. We checked that our manuscript meets PLOS ONE’s style requirements and revised our manuscript according to PLOS ONE’s style requirements. 2. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. Thank you for your comment. We checked and revised our references. Additional Editor Comments: The submitted manuscript is well executed and will contribute to the body of knowledge. Please address the points outlined by the reviewers in your revision. Thank you very much for your compliment. Below, we respond to the reviewers’ remarks (in bold) and include direct quotes from the manuscript (in italics) point-by-point. REVIEWERS’ COMMENTS: Reviewer #1 I would like to thank the editor for the opportunity to review the manuscript entitled "Prospective comparative analysis of noninvasive body temperature monitoring using zero heat flux technology (SpotOn sensor) compared with esophageal temperature monitoring during pediatric surgery". The paper is well-written and the study has been well designed and described. Monitoring body temperature in the clinical setting is of great importance and one of the greatest challenge is represented by the need to measure or estimate core body temperature values with as less invasive as possible techniques due to several limitation that can depend on the setting or patient. This study provides a comparison between a non-invasive device (SpotOn) based on the ZHF technology, and a standard-use technology in ICU or surgery, as the esophageal temperature, in a specific population, i.e., pediatric surgery patients. The results suggest a good agreement between the techniques, but some limitations can be also considered as the time needed to reach good agreement values, and some poor readings when temperature is < 36.5 Based on these considerations, the manuscript is worth of publication; however, I have few suggestions I would like to make before acceptance. In general, I suggest to expand the references a little bit, by adding some papers and reviews on this topic. - Introduction: Correctly the authors state that few studies are present about the validation of ZHF in pediatric patients (lines 73-74). Can the authors cite here some of the papers that are already present in the literature, or some reviews? (e.g., Lee et al., 2021; Nemeth et al., 2020, Carvalho et al., 2019; Morettini et al., 2020; Conway et al., 2021). Thank you for your comment and we are sorry for not providing some references. We cited a reference as follows. Introduction section: “However, few studies have been conducted in pediatric patients[15].” Reference section: “15. Carvalho H, Najafi N, Poelaert J. Intra-operative temperature monitoring with cutaneous zero-heat- flux-thermometry in comparison with oesophageal temperature: A prospective study in the paediatric population. Paediatr Anaesth. 2019;29(8):865-71. Epub 2019/04/30. doi: 10.1111/pan.13653. PubMed PMID: 31034706.” - Results: Results are well presented, although since the authors present the "temperature zones" analysis, it might be interesting to know how many readings were found in each zone for the esophageal probe. Indeed, since it is reported the lower agreements are present when temperature is < 36.5 °C, it might be important to understand how much common such zone can be during such surgery in pediatric patients. Thank you for your advice. We totally agree to your comment. According to your comment, we specify percentage of each zone for the esophageal probe. Of the 466 data pairs, the zone of esophageal temperature < 36.5°C consists of 64 data pairs, which accounted for 13.7%. The zone of esophageal temperature 36.5-37.5°C and >37.5°C each accounted for 362 data pairs (77.7%) and 40 data pairs (8.6%). In this study, since the patients were relatively healthy and the exposure of the surgical field was very narrow, the body temperature during surgery tends to rise rather than drop. It is expected that the proportion of the low body temperature section will be higher in the case of vulnerable children in emergency surgery or in the case of wide exposure to the surgical field. We revised the manuscript as follows. Result section: “Of the 466 data pairs, the zone of esophageal temperature < 36.5°C consists of 64 data pairs, which accounted for 13.7%. The zone of esophageal temperature 36.5-37.5°C and >37.5°C each accounted for 362 data pairs (77.7%) and 40 data pairs (8.6%).” - Discussion: Based on these findings, I would suggest to well highlight the limitations about the validity of the ZHF system (i.e., time after induction + low body temperature), and maybe provide some sort of recommendations for its use (e.g., to wait n minutes before considering the measurement correct, or to be careful when <36.5 °C is expected). Thank you for your suggestion. We strongly agree to your advice. We revised the manuscript as follows. Discussion section: “These results suggest that the accuracy of the ZHF sensor may be limited in the initial stage after induction or when the body temperature is 36.5°C or less. Based on these results, it is necessary to have doubts about the measured value before the ZHF system is stabilized after induction. In addition, it is recommended that caution is required in interpreting the ZHF sensor value in situations in which the body temperature can be less than 36.5°C, that is, in the cases of emergency surgeries that tend to show unstable body temperature, or in the cases of large exposure to the surgical site.” Reviewer #2 In the present study, the authors sought to validate the non-invasive “SpotOn” measurement technic for estimating core temperature against esophageal temperature in children undergoing surgery. The authors found exceptionally good agreement of the SpotOn method. My only comment is that I wish the authors had also compared to other acceptable non-invasive methods for measuring core temperature, such as surface temperature over the carotid (Jay et al, 2013, Pediatric Anesthesia; Imani et al, 2016, Anesthesiology and pain medicine). The authors should mention this technic in their intro and discussion, however, SpotOn had better agreement in this study than surface carotid temperature in those other studies, and therefore mentioning these studies should only serve to strengthen the argument for this new technic. Minor comments below. Great job! Thank you for your advice. According to your comment, we revised the manuscript as follows. Introduction section: “Infrared skin temperature measurement of the upper temporal artery and skin temperature measurement over the carotid artery have been suggested as alternatives to measuring core body temperature with less invasive methods. However, these methods seem to have limitations in their clinical use due to insufficient accuracy of core temperature measurement.” Discussion section: “The temporal-artery thermometer and skin temperature over carotid artery, which were suggested as less invasive alternatives to measuring core temperature, were insufficiently accurate for clinical application. In comparison with these methods, the correlation and aggrement between the ZHF sensor and the core temperature represented by the esophageal temperature show more reliable results.” P3, L28 – Missing space after period Thank you for your comment. We revised the manuscript as follows. Abstract section: “intraoperatively. Children” P3, L30 – Missing space after period Thank you for your comment. We revised the manuscript as follows. Abstract section: “enrolled. Body” P3, L37 – This should be -0.07, shouldn’t it? Thank you for your comment and we are sorry for our mistake. We revised the manuscript as follows. Abstract section: “-0.07” P6, L108 – Double ref 10 Thank you for your comment and we are sorry for our mistake. We deleted one reference. Reviewer #3 The current manuscript compares the SpotOn sensor to esophageal and axillary temperatures during elective pediatric surgery. Collectively, I have little issues with the manuscript and the statistical analysis done. In my opinion, the purpose of the study has been justified and well executed. However, the main concern I have with the findings is the weaker relationship between esophageal temperature and the SpotOn sensor at lower internal temperatures (<36.5C). In my opinion, this should be more thoroughly highlighted in the discussion, especially when the authors allude to emergency patients (whom still need to be investigated) having greater vulnerability to impaired thermoregulatory control. Thank you for your comment and we are sorry for insufficient description regarding the weaker relationship between esophageal temperature and the SpotOn sensor at lower body temperature (<36.5°C). We revised the manuscript as follows. Discussion section: “These results suggest that the accuracy of the ZHF sensor may be limited in the initial stage after induction or when the body temperature is 36.5°C or less. Based on these results, it is necessary to have doubts about the measured value before the ZHF system is stabilized after induction. In addition, it is recommended that caution is required in interpreting the ZHF sensor value in situations in which the body temperature can be less than 36.5°C, that is, in the cases of emergency surgeries that tend to show unstable body temperature, or in the cases of large exposure to the surgical site.” Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0272720.r002
26 Jul 2022 Decision Letter - William M. Adams, Editor Prospective comparative analysis of noninvasive body temperature monitoring using zero heat flux technology (SpotOn sensor) compared with esophageal temperature monitoring during pediatric surgery PONE-D-22-17177R1 Dear Dr. Sang, 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, William M. Adams Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0272720.r003
Formally Accepted
29 Jul 2022 Acceptance Letter - William M. Adams, Editor PONE-D-22-17177R1 Prospective comparative analysis of noninvasive body temperature monitoring using zero heat flux technology (SpotOn sensor) compared with esophageal temperature monitoring during pediatric surgery Dear Dr. Sang: 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. William M. Adams Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0272720.r004

Open letter on the publication of peer review reports

PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.

We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.

Learn more at ASAPbio .