Tracheostomy in COVID-19 acute respiratory distress syndrome patients and follow-up: A parisian bicentric retrospective cohort

Diane Evrard; Igor Jurcisin; Maksud Assadi; Juliette Patrier; Victor Tafani; Nicolas Ullmann; Jean-François Timsit; Philippe Montravers; Béatrix Barry; Emmanuel Weiss; Sacha Rozencwajg

doi:10.1371/journal.pone.0261024

Peer Review History

Original SubmissionJune 25, 2021
23 Aug 2021 Decision Letter - Robert Jeenchen Chen, Editor PONE-D-21-20812 Tracheostomy in COVID-19 acute respiratory distress syndrome patients and follow-up: a parisian bicentric retrospective cohort PLOS ONE Dear Dr. Evrard, 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 address the issues and revise accordingly. Please submit your revised manuscript by Oct 07 2021 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. 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Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: 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: Evrard et al. describe their single center experience on tracheostomies in patients with COVID-19 and ARDS. Overall, the manuscript is well-written and the statistics are appropriate. Major concern: There are a significant number of publications on outcomes after tracheostomies for COVID-19. While the authors note their longer-term follow-up, I am worried there is somewhat limited new information in this topic. Further discussion into long-term follow-up outcomes, and investigation of associations of complications/long-term effects may be helpful to add new information to existing literature. Reviewer #2: I read with interest about this study about tracheostomy in COVID-19 patients. Generally, it provided an overview of tracheostomy during early pandemic. Several issues should be further clarified. Major: 1. In the current study, all surviving patients were weaned from mechanical ventilation and finally decannulated. However, in previous publised studies, mean ventilator weaning rate was less than 60% and mean decannulation rate was less than 40%. How to explain these differences? 2. Several factors were associated with difficult weaning and prolonged decannluation process. The authors should provide more details on the enrolled subjects (Severity of ARDS, severity scoring, such as APACHE II, SOFA, etc, underlying diseases, such as COPD, ILDs, malignancy) 3. Several factors had statistically significant differences between early and late tracheostomy groups. However, they were not mentioned in the result section and the possible mechanism should be addressed in the discussion section. Minor: 1. METHODS "The study was approved by the appropriate Institutional Review Board (IRB), and written informed consent was obtained from all subjects." "The study was approved by the local ethical committee and informed consent was waived as part of a public health outbreak investigation." It will make readers confusion about whether informed consents were available or not? 2. RESULTS During the study period, among 1.733 patients hospitalized for COVID-19 at Bichat and Beaujon University Hospitals, 300 were hospitalized in ICU, all requiring invasive MV. →1.733 should be 1733 3.Distant head and neck complications The term "distant" was not used frequently in medical literature. Please provide a better terminology. 4. Discussion Potential benefits and harms of tracheostomy during the COVID-19 pandemic → It was not frequent seen that a subheading present in the discussion section. Please integrate it into discussion paragraph. ****** 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: Yes:** Wei-Chih Chen [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.0261024.r001
Revision 1
12 Oct 2021 Author Response Dr Diane EVRARD Department of Head and Neck Surgery Bichat University Hospital, Assistance Publique—Hôpitaux de Paris 46 Rue Henri Huchard, 75877 Paris, France, Telephone: +33677846800 email: evrard.diane@gmail.com Professor Emily Chenette, PhD Editors-in-Chief, PLOS One 6th October 2021, Dear Professor, Please find attached the revised version of our manuscript entitled “Tracheostomy in COVID-19 acute respiratory distress syndrome patients and follow-up: a Parisian bicentric retrospective cohort”, by Evrard et al., that we are revising for publication in PLOS One. We sincerely thank you and the Reviewers for the considerable work incurred reviewing our manuscript. We think that all your constructive comments and suggestions have markedly contributed to improving the quality and readability of our paper. Changes made in the text are in red as instructed. We hope that you and the Reviewers find our changes adequate and our paper acceptable for publication. We look forward to hearing from you soon. Sincerely yours. Diane EVRARD on behalf of the authors Reviewer 1 Comments to Author: Evrard et al. describe their single-centre experience on tracheostomies in patients with COVID-19 and ARDS. Overall, the manuscript is well-written and the statistics are appropriate. We would like to thank Reviewer 1 for their appreciation of our work. Major concern: There are a significant number of publications on outcomes after tracheostomies for COVID-19. While the authors note their longer-term follow-up, I am worried there is somewhat limited new information in this topic. Further discussion into long-term follow-up outcomes, and investigation of associations of complications/long-term effects may be helpful to add new information to existing literature. We agree with Reviewer #1 that several publications have become available regarding tracheostomies in patients with COVID-19 and that our results are concordant with most of the literature published on this topic. Nevertheless, we believe two things are important and should be noted: 1) We believe it is important for the readers to obtain more data regarding tracheostomies in patients with COVID-19 as this is most likely to be correct for any upcoming respiratory pandemic and therefore even though our study doesn’t bring any novelty in this field, it may be of importance to the readers; 2) We bring novelty by having reported long-term outcomes specifically linked to tracheostomies in this specific population, and we believe it is major for healthcare professionals to be aware of these complications, especially for those who are not used to this specific literature, not reported elsewhere. Piazza et al. underlined the increase of long-term airways complications due to intubations and tracheostomies for COVID-19 patients and asks for a real “call to action”. We have emphasized this in the discussion (Page 14) and hope that those arguments would make Reviewer #1 consider favorably our manuscript for PLOS One. Reviewer 2 Comments to Author: I read with interest about this study about tracheostomy in COVID-19 patients. Generally, it provided an overview of tracheostomy during early pandemic. Several issues should be further clarified. We would like to thank Reviewer 2 for their appreciation of our work. Major: In the current study, all surviving patients were weaned from mechanical ventilation and finally decannulated. However, in previous published studies, mean ventilator weaning rate was less than 60% and mean decannulation rate was less than 40%. How to explain these differences? As we indicated in the manuscript, Benito et al performed a review of tracheostomy for COVID-19 patients and reported a weaning rate up to 89.3% and a decannulation rate up to 96.6%. These high rates corresponded to Williamson et al. study in which the population of 29 patients was similar to our cohort. We believe that these differences may be explained by several factors in our study: 1. For “late tracheostomies”. These late procedures are performed in our centers after a risk-benefits balance is weighed and the patient’s risk of death is considered minimal. Thus - because of our habits - “risk of weaning” and “late tracheostomy” could almost be statistically considered as competing factors, which may explain the absence of death in the late tracheostomy group. 2. For “early tracheostomies”. a. As mentioned in the manuscript, patients eligible for an early tracheostomy were less severe: only 30% were proned, none were on ECMO, only 1 patient had RRT (even if ECMO and RRT are not statistically different due to our limited number of patients). Therefore, we believe the overall good prognosis of our patients is explained by the selection of patients eligible for an early tracheostomy. b. Also, our study takes place during the “first wave” during which it is now known that intubation was probably “overused” at the initial part of the disease even if patients did meet ARDS criteria. Nevertheless, we believe this explanation does not totally fit our population as driving pressure at intubation was relatively low - corresponding to a “type L” phenotype - and comparable with the late tracheostomy group. 2. Several factors were associated with difficult weaning and prolonged decannulation process. The authors should provide more details on the enrolled subjects (Severity of ARDS, severity scoring, such as APACHE II, SOFA, etc, underlying diseases, such as COPD, ILDs, malignancy) As requested, we have added details in enrolled subjects: - Severity of ARDS: we added the respiratory parameters during the first 24 hours of ventilation (PF ratio and PEEP) as well as the number of prone positioning; - Severity scoring: we added the APACHE II and SOFA at ICU admission; - Underlying diseases: - COPD: there was a typo in the table as “COPD” and “asthma” were regrouped under the term “asthma”. We now separated them and provided details under Table 1 “a”; - ILDS: none of our patients had chronic interstitial lung disease - immunosuppression: we detailed it under Table 1 “b”. 3. Several factors had statistically significant differences between early and late tracheostomy groups. However, they were not mentioned in the result section and the possible mechanism should be addressed in the discussion section. Regarding the statistical differences between early and late, all of them are mentioned in the results section: - characteristics: difference for “hospital admission to MV” and for “prone positioning” reported in the paragraph Comparison between early and late tracheostomies - outcomes: differences in length of stay in ICU or at hospital and duration of MV which are reported in the same paragraph. We agree this was not mentioned in the discussion paragraph, we therefore added the following sentence (Page 16) : “We even report here that patients had a significantly shorter time in ICU, in hospital and on mechanical ventilation. This is most likely due to the selection of our population who would benefit from an early tracheostomy. Indeed, “late tracheostomies” were performed after a risk-benefits balance had been clearly weighed and the patient's risk was considered minimal. On the other side, “early tracheostomies” were performed on patient that were less severe with only 30% proned, none on ECMO, and only one patient had renal replacement therapy.” Minor: 1. METHODS "The study was approved by the appropriate Institutional Review Board (IRB), and written informed consent was obtained from all subjects." "The study was approved by the local ethical committee and informed consent was waived as part of a public health outbreak investigation." It will make readers confused about whether informed consents were available or not? We agree with Reviewer #2 that this paragraph induces confusion. We have obtained an IRB approval to collect all data on COVID-19 patients and consent was waived for this study. We, therefore, deleted the “and written informed consent was obtained from all subjects” and regrouped the two paragraphs into one. 2.RESULTS During the study period, among 1.733 patients hospitalized for COVID-19 at Bichat and Beaujon University Hospitals, 300 were hospitalized in ICU, all requiring invasive MV. →1.733 should be 1733 The typo has been corrected. 3.Distant head and neck complications The term "distant" was not used frequently in the medical literature. Please provide better terminology. We have replaced the term “distant” with “long-term”. Please excuse our “Frenchism”. 4. DISCUSSION. Potential benefits and harms of tracheostomy during the COVID-19 pandemic → It is not frequently seen that a subheading is present in the discussion section. Please integrate it into the discussion paragraph. We have deleted the subheading into the discussion paragraph as requested. Editors Comments to Author: 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 We have corrected the references style. 2. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. We have added our data table. 3. We note that you have included the phrase “data not shown” in your manuscript. Unfortunately, this does not meet our data sharing requirements. PLOS does not permit references to inaccessible data. We require that authors provide all relevant data within the paper, Supporting Information files, or in an acceptable, public repository. Please add a citation to support this phrase or upload the data that corresponds with these findings to a stable repository (such as Figshare or Dryad) and provide and URLs, DOIs, or accession numbers that may be used to access these data. Or, if the data are not a core part of the research being presented in your study, we ask that you remove the phrase that refers to these data. We have deleted this sentence. 4. Please upload a new copy of Figure 1 and Figure 2 as the detail is not clear. Please follow the link for more information: https://blogs.plos.org/plos/2019/06/looking-good-tips-for-creating-your-plos-figures-graphics/" https://blogs.plos.org/plos/2019/06/looking-good-tips-for-creating-your-plos-figures-graphics/ We have increased the dpi of each figure. Attachments Attachment Submitted filename: Responses to reviewers_PLOS one.docx https://doi.org/10.1371/journal.pone.0261024.r002
23 Nov 2021 Decision Letter - Sebastian Shepherd, Editor Tracheostomy in COVID-19 acute respiratory distress syndrome patients and follow-up: a parisian bicentric retrospective cohort PONE-D-21-20812R1 Dear Dr. Evrard, 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, Sebastian Shepherd Associate Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #2: All comments have been addressed ******** 2. 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: Yes Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes ****** 4. 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 ****** 5. 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 ****** 6. 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: The authors have improved their manuscript and addressed my comments. Overall additional long-term information on tracheostomies in COVID patients can be of value. Reviewer #2: The authors addressed reviewers' and editor's comment adequately. I suggested the manuscript accepted for publication. ****** 7. 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 https://doi.org/10.1371/journal.pone.0261024.r003
Formally Accepted
9 Dec 2021 Acceptance Letter - Sebastian Shepherd, Editor PONE-D-21-20812R1 Tracheostomy in COVID-19 acute respiratory distress syndrome patients and follow-up: a parisian bicentric retrospective cohort Dear Dr. Evrard: 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 Sebastian Shepherd Staff Editor PLOS ONE https://doi.org/10.1371/journal.pone.0261024.r004

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