Utility of the ROX Index in Predicting Intubation for Patients With COVID-19–Related Hypoxemic Respiratory Failure Receiving High-Flow Nasal Therapy: Retrospective Cohort Study

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Abstract

The use of high-flow nasal therapy (HFNT) to treat COVID-19 pneumonia has been greatly debated around the world due to concerns about increased health care worker transmission and delays in invasive mechanical ventilation (IMV). Herein, we analyzed the utility of the noninvasive ROX (ratio of oxygen saturation) index to predict the need for and timing of IMV.

Objective

This study aimed to assess whether the ROX index can be a useful score to predict intubation and IMV in patients receiving HFNT as treatment for COVID-19–related hypoxemic respiratory failure.

Methods

This is a retrospective cohort analysis of 129 consecutive patients with COVID-19 admitted to Temple University Hospital in Philadelphia, PA, from March 10, 2020, to May 17, 2020. This is a single-center study conducted in designated COVID-19 units (intensive care unit and other wards) at Temple University Hospital. Patients with moderate and severe hypoxemic respiratory failure treated with HFNT were included in the study. HFNT patients were divided into two groups: HFNT only and intubation (ie, patients who progressed from HFNT to IMV). The primary outcome was the value of the ROX index in predicting the need for IMV. Secondary outcomes were mortality, rate of intubation, length of stay, and rate of nosocomial infections in a cohort treated initially with HFNT.

Results

Of the 837 patients with COVID-19, 129 met the inclusion criteria. The mean age was 60.8 (SD 13.6) years, mean BMI was 32.6 (SD 8) kg/m², 58 (45%) were female, 72 (55.8%) were African American, 40 (31%) were Hispanic, and 48 (37.2%) were nonsmokers. The mean time to intubation was 2.5 (SD 3.3) days. An ROX index value of less than 5 at HFNT initiation was suggestive of progression to IMV (odds ratio [OR] 2.137, P=.052). Any further decrease in ROX index value after HFNT initiation was predictive of intubation (OR 14.67, P<.001). Mortality was 11.2% (n=10) in the HFNT-only group versus 47.5% (n=19) in the intubation group (P<.001). Mortality and need for pulmonary vasodilators were higher in the intubation group.

Conclusions

The ROX index helps decide which patients need IMV and may limit eventual morbidity and mortality associated with the progression to IMV.

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  1. SciScore for 10.1101/2020.06.30.20143867: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was approved by the Temple University Institutional Review Board (TU-IRB protocol number: 27051).
    Consent: A waiver of consent was granted due to the acknowledged minimal risk to the patients.
    RandomizationPatients with RT-PCR positive swabs were also screened for eligibility for randomized controlled trials at our institution which included sarilumab (Regeneron Pharmaceuticals; NCT04315298), remdesivir (Gilead Sciences; NCT04292730 and NCT04292899), gimsilumab (Kinevant Sciences: NCT04351243), and convalescent plasma (Mayo Clinic; NCT04338360).
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    All statistical analyses were performed with the use of Stata 14.0 (StataCorp LP, College Station, TX).
    StataCorp
    suggested: (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 several limitations. First, it is a retrospective review, thus making it susceptible to unintended biases. Developing a prospective study during a pandemic situation was impractical. Secondly, although this is the largest HFNT study, the total N is limited and representative of a singles center’s experience. Lastly, we were unable to provide consistent details on the presence and degree of hypercapnia for our cohort due to our institutional policy to minimize staff exposure to COVID-19 infection. In conclusion, the ROX index provides an accurate risk stratification tool in patients with moderate to severe hypoxemic respiratory failure secondary to COVID-19 pneumonia. HFNT can be safely and successfully implemented while utilizing the ROX index to predict the need for IMV. Monitoring ROX trends may allow clinicians to avoid any significant delays in escalating the level of care or implementing IMV. Use of HFNT not only reduces intubation rates, but also has the potential to reduce mortality and morbidity associated with IMV.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04315298CompletedEvaluation of the Efficacy and Safety of Sarilumab in Hospit…
    NCT04292730CompletedStudy to Evaluate the Safety and Antiviral Activity of Remde…
    NCT04292899CompletedStudy to Evaluate the Safety and Antiviral Activity of Remde…
    NCT04351243Active, not recruitingA Study to Assess the Efficacy and Safety of Gimsilumab in S…
    NCT04338360Approved for marketingExpanded Access to Convalescent Plasma for the Treatment of …


    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.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.