Tracheotomy Outcomes in 71 COVID-19 Patients: A Multi-Centric Study in Saudi Arabia

Round 1

Reviewer 1 Report

I have read this small but fairly performed study with great interest. Main concern is novelty provided with these results as authors do not clearly argument what is new besides regional significance. Also, the paper is lacking the limitations section at the end of discussion where main limitations would be clearly stated (retrospective design, small sample size and low statistical power for some of analyses, single center experience, etc.). 

Author Response

Thank you for your comments and suggestions,

in regards to the first point: "Main concern is novelty provided with these results as authors do not clearly argument what is new besides regional significance";

As mentioned, our study is the first study conducted in Saudi Arabia that included patient sample from 2 main centers in Jeddah, the second city after the capital in population numbers and health advancement. Also, our average intubation days before tracheostomy was 9.97 days in comparison to 19.7± 6.9 days that was reported in previous literatures. Furthermore, our overall 30-day mortality rate was 38.4% while it ranged from 7%-41% in former reports.

in regards to the second point: lacking the limitations section; 

we agree and this paragraph will be added to the discussion in the revise manuscript,

" this study identify tracheostomy in COVID-19 patients as an effective and safe weaning tool, however, there are some major limitations that could be addressed in future research, (1) the small sample size, (2) the study design, and (3) the inconsistent reporting of data in the medical charts which might be explained by  pandemic burden and the limited personnel and resources." 

Reviewer 2 Report

Review of „Tracheotomy Outcomes in 71 COVID-19 Patients: A Multi-Centric Study in Saudi Arabia“

Thank you for the opportunity to review the paper mentioned above. In their work, Almutairi and co-workers evaluate the outcomes of tracheostomy in intubated COVID-19 patients in Saudi Arabia.

There were several findings, like average period between intubation and tracheostomy or significant risk factors of mortality and the overall 30-day mortality rate.

However, I would not argue, that, by those findings, tracheostomy is an effective and safe weaning tool.

Here are my remarks:

Abstract

Line 23:

“The findings of the study revealed seventy-one with COVID-19 underwent tracheotomy between March 1, 2020 and October 31, 2020.”  I think, a word (“patient”) is missing.

Line 26 ff.:

“The overall 30-day mortality rate was 38.4%. The study concluded that tracheostomy is an effective and safe weaning tool.”

There are several studies numbering the average ICU mortality between 25 and 30%, For me, an overall 30-day mortality rate of 38.4% seems fairly high. To argue, that tracheostomy is a safe weaning tool in this context, seems rather implausible – consider revision.

Overall the abstract needs grammatical revision.

Introduction

Line 34 ff:

To date, reports from Saudi Arabia reveled a 548 thousand confirmed case and almost 8000 death, yielding the country an advanced place in terms of effectively combating the disease.

“Reveal” instead of “revel”?

“Deaths” instead of “death”?

Line 45 ff:

“When compared to endotracheal intubation, tracheostomy ensure lesser need for sedation, decreased work of breathing, better patient communication, improved weaning, and most importantly, reduced risk of laryngeal and tracheal stenosis.”

Either “tracheostomies” or “ensures” – please revise.

Line 50 ff:

“As tracheostomy is considered an aerosol generating procedure (AGP) that increase the risk of viral exposure and transmission, international guidelines suggest delaying its use among intubated patients with COVID-19.”  

Either “tracheostomies” or “increases” – please revise.

Line 55:

“However, early tracheostomy may be urgently indicated in life-threatening situations in which tracheostomy would significantly increase survival rate.”

Like what? Please provide examples.

Line 60:

“In this study, we aim to investigate the outcomes of tracheostomy in intubated COVID-19 patients in two centers in Jeddah, Saudi Arabia”

Point missing

Materials and Methods:

Line 70:

“…done by ICU consultant between March 1, 2020, and…”

An “an” is missing.

Line 83:

“The information and data are saved and stored digitally in a password protected work-based computer, only accessed by the investigators.”

Different tenses – revise.

“Ethics”:

Please provide number of ethics board decision/ reference.

Results:

Table 3

This table contains a fairly high percentage of patients aged < 40 yrs. – Please explain

Line 129:

“from the tracheostomy site (15.5%, 11 of 71), followed by the mucous plug”

What is the mucous plug? Please explain.

Discussion

Line 146:

“Since its outbreak in late 2020,” – it should read 2019, shouldn´t it?

Consider grammatic revision – “;” is used unnecessarily

Line 165:

“The timing of tracheostomy among COVID-19 patients is still controversial and several guidelines on this topic have not yet reached consensus.”

Agree – but please provide examples.

All in all a nice work, but its contribution to the scientific community is not clear to me.  

Author Response

Please see the attachment.

Author Response File: Author Response.pdf

Reviewer 3 Report

Thanks for allowing me to review this interesting paper.

In their work Dakheelallah Almutairi and collegues described their experience with tracheostomy in two ICUs, according to the retrospective design of the study.

While the novelty of the work is low (there are a lot of papers on tracheostomy during covid-19 pandemic, and many are cited by the authors) this is one of the few works describing the situation in Saudi Arabia.
Considering the limitations related to the design of the study I have the followig comments:

• Statistics and Data Analysis: Which test was used to assess the normality of the variables?
• Statistics and Data Analysis: In table 1 you present age as median [interquartile range], please present it as mean (sd) or clarify in the methods that when the variables were non-normal they were presented with median [IQR]
• Statistics and Data Analysis: Which test did you use comparing continous variables? Please clarify it in the methods.
• Results: do you have the total number of treated patients? I would add it to the test to understand the n (%) of patients that recieved a tracheostomy, in proportion to the total of covid-19 treated in the icu that required endotracheal intubation.
• Results: do you have any clinical data that could help understanding the severity of the studied population? PaO2/FiO2, PaCO2, bilateral chest x ray, oxygen requirement at ICU arrival, etc. 
• Results: please, present the results as mean (SD) or median [IQR] as appropriate. Do not give only the mean value.
• Table 2:  please, present the results as mean (SD) or median [IQR] as appropriate. Do not give only the mean value.
• Results: when assessing the correlation between risk factors and mortality after tracheostomy give the odds ratio.
• Table 3: to increase the clarity for the reader, I would slightly modify the table adding the total number of cases and number of patients (%). It would be as follows:
  prognostic variable|category (total number)| non survivors (n %) | survivors (n%) | p value
• Discussion: page 6, line 172-175: you cite two works with conflicting results, please, rephrase the sentence more clearly

Author Response

Thank you so much for your review

We will do our best

Point 1: Statistics and Data Analysis: Which test was used to assess the normality of the variables?


Response 1: Shapiro–Wilk test

Point 2: Statistics and Data Analysis: In table 1 you present age as median [interquartile range], please present it as mean (sd) or clarify in the methods that when the variables were non-normal they were presented with median [IQR]

Response 2: Noted and will be added to the table and will be mentioned in methodology section

Point 3: Statistics and Data Analysis: Which test did you use comparing continuous variables? Please clarify it in the methods.

Response 3: T-test, Noted and will be added to the methodology section

Point 4: Results: do you have the total number of treated patients? I would add it to the test to understand the n (%) of patients that recieved a tracheostomy, in proportion to the total of covid-19 treated in the icu that required endotracheal intubation.

Response 4: unfortunately, we don’t have it

Point 5: Results: do you have any clinical data that could help understanding the severity of the studied population? PaO2/FiO2, PaCO2, bilateral chest x ray, oxygen requirement at ICU arrival, etc.

Response 5: unfortunately, we didn’t recruit these data

Point 6: Results: please, present the results as mean (SD) or median [IQR] as appropriate. Do not give only the mean value.

Response 6: noted and we will modify the table

Point 7: Table 2:  please, present the results as mean (SD) or median [IQR] as appropriate. Do not give only the mean value.

Response 7: noted and we will modify the table

Point 8: Results: when assessing the correlation between risk factors and mortality after tracheostomy give the odds ratio.

Response 8: noted

Point 9: to increase the clarity for the reader, I would slightly modify the table adding the total number of cases and number of patients (%). It would be as follows: prognostic variable category (total number)| non survivors (n %) | survivors (n%) | p value

Response 9: it’s clearly mentioned in table 1

Point 10: Discussion: page 6, line 172-175: you cite two works with conflicting results, please, rephrase the sentence more clearly

Response 10: Timing of tracheotomy is controversial, and we mentioned multiple studies with different outcomes, it is not conflicting results.   

Author Response File: Author Response.pdf

Round 2

Reviewer 1 Report

Revision is satisfactory. Thank you.

Author Response

Thank you so much for your feedback 

Reviewer 2 Report

The manuscript has certainly gained quality through revision, but I think it definitely needs some native English revision. 

Author Response

Thank you so much for your feedback 

Our research had been edited by MDPI editing service and I uploaded the revised and edited version for you to check. Thank you again 

Author Response File: Author Response.docx

Reviewer 3 Report

Dear authors,

Thanks for your point-to-point answer to my comments. 
I see that you clarified many points, which i apprecciated.
Unfortunately it was not possible for the authors to collect the additional data needed to help the reader understand the severity of the disease. 

Neverthless, i think that the work is overall well done, and i do not have further comments.

Author Response

Thank you so much for your feedback