Timing of elective tracheotomy and duration of mechanical ventilation among patients admitted to intensive care with severe COVID ‐19: A multicenter prospective cohort study
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Abstract
Background
Optimal timing for tracheotomy for critically ill COVID‐19 patients requiring invasive mechanical ventilation (IMV) is not established.
Methods
Multicenter prospective cohort including all COVID‐19 patients admitted to intensive care units (ICUs) in 36 hospitals who required tracheotomy during first pandemic wave. With a target emulation trial framework, we studied the causal effects of early (7–10 days) versus late (>10 days) tracheotomy (LT) on time from tracheotomy to weaning, postoperative mortality, and tracheotomy complications.
Results
Of 696 patients, 20.4% received early tracheotomy (ET). ET was associated with faster weaning (hazard ratio [HR] [95% confidence interval, CI]: 1.25 [1.00–1.56]) without differences in mortality (HR [95% CI]: 0.85 [0.60–1.21]) or complications (adjusted rate ratio [95% CI]: 0.56 [0.23–1.33]).
Conclusions
ET had a similar or lower post‐tracheotomy weaning time than LT, potentially shortening IMV and ICU stays, without changing complication or mortality rates in COVID‐19 patients.
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SciScore for 10.1101/2021.01.22.21249651: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Ethical approval and informed consent: The local ethics committee approved the study protocol and waved informed consent given the observational nature of the study.
IRB: Ethical approval and informed consent: The local ethics committee approved the study protocol and waved informed consent given the observational nature of the study.Randomization not detected. Blinding not detected. Power Analysis We calculated post-hoc power calculations using the Freedman method (21). Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources We performed data management in SPSS 27 (IBM Corp. SPSSsuggested: (SPSS, RRID:SCR_002865)We … SciScore for 10.1101/2021.01.22.21249651: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Ethical approval and informed consent: The local ethics committee approved the study protocol and waved informed consent given the observational nature of the study.
IRB: Ethical approval and informed consent: The local ethics committee approved the study protocol and waved informed consent given the observational nature of the study.Randomization not detected. Blinding not detected. Power Analysis We calculated post-hoc power calculations using the Freedman method (21). Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources We performed data management in SPSS 27 (IBM Corp. SPSSsuggested: (SPSS, RRID:SCR_002865)We performed all analyses in STATA version 16.0 (StataCorp. 2019. Stata Statistical Software: Release 16. STATAsuggested: (Stata, RRID:SCR_012763)StataCorpsuggested: (Stata, RRID:SCR_012763)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Our study has limitations as well as strengths. The study design and inclusion criteria prevented us from analysing the causal effects of tracheotomy timing on total days of IMV. Although the observed differences in total IMV duration post-tracheotomy described here are attributable to the tracheotomy timing, the observed differences in total duration of IMV were artificially inflated by immortal time bias (31) and should not be interpreted as causal estimates. A randomised controlled trial with an intention-to-treat analysis would be preferable to establish the effect of early tracheotomy on the total duration of IMV for patients admitted to ICU with COVID-19, although it is unlikely that it can be performed in the pandemic scenario. As we used observational data, one can argue that residual confounding could be at least partially responsible for the observed findings. However, although the groups were not totally comparable, we did not find any evidence of confounding by indication, with baseline characteristics well balanced between the early and late tracheotomy groups. Moreover, multivariable adjustment including APACHE II, SOFA, PAFI, PEEP and pronation did not attenuate the observed effects, with a good statistical power. Among the strengths of the present study are the large number of participants and the prospective cohort design. We designed the analyses following a trial emulation framework (32) with randomisation at day 7 of intubation for robustness. Using multip...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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