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Awake Proning: Current Evidence and Practical Considerations.

ABSTRACT: Prone positioning has been shown to improve oxygenation for decades. However, proning in awake, non-intubated patients gained acceptance in the last few months since the onset of coronavirus (COVID-19) pandemic. To overcome the shortage of ventilators, to decrease the overwhelming burden on intensive care beds in the pandemic era, and also as invasive ventilation was associated with poor outcomes, proning of awake, spontaneously breathing patients gathered momentum. Being an intervention with minimal risk and requiring minimum assistance, it is now a globally accepted therapy to improve oxygenation in acute hypoxemic respiratory failure in COVID-19 patients. We thus reviewed the literature of awake proning in non-intubated patients and described a safe protocol to practice the same. How to cite this article: Sodhi K, Chanchalani G. Awake Proning: Current Evidence and Practical Considerations. Indian J Crit Care Med 2020;24(12):1236-1241.

SUBMITTER: Sodhi K

PROVIDER: S-EPMC7775938 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Awake Proning: Current Evidence and Practical Considerations.

Sodhi Kanwalpreet K Chanchalani Gunjan G

Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine 20201201 12

Prone positioning has been shown to improve oxygenation for decades. However, proning in awake, non-intubated patients gained acceptance in the last few months since the onset of coronavirus (COVID-19) pandemic. To overcome the shortage of ventilators, to decrease the overwhelming burden on intensive care beds in the pandemic era, and also as invasive ventilation was associated with poor outcomes, proning of awake, spontaneously breathing patients gathered momentum. Being an intervention with mi ...[more]

PMID: 33446979

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Project description:ABP 980 (KANJINTI™, Amgen, Thousand Oaks, CA, USA; Amgen Europe B.V., The Netherlands) is a biosimilar to trastuzumab (Herceptin®), a monoclonal antibody that selectively binds human epidermal growth factor receptor-2 (HER2). Here we provide a brief overview of the totality of evidence (including analytical [structural and functional] characterization, nonclinical evaluation, and human pharmacokinetic [PK], pharmacodynamic, and clinical assessment comparing ABP 980 with trastuzumab reference product [RP]) that supported the approval of ABP 980, along with practical considerations on the reconstitution and use of the lyophilized product to ensure safe and effective administration. ABP 980 has been shown to be highly similar to the RP, with similar mechanism of action, binding, and potency. Key PK parameters, geometric means ratio (GMR [90% CI]) of Cmax and AUCinf, are comparable and within the equivalence margin of 0.80 to 1.25 (ABP 980: 1.04 [0.99-1.08] versus trastuzumab US: 1.06 [1.00-1.12]; ABP 980: 0.99 [0.95-1.03] versus trastuzumab EU: 1.00 [0.95-1.06]). No clinically meaningful differences were found between ABP 980 and RP in a comparative clinical trial in patients with HER2-positive early breast cancer. Pathological complete response-ABP 980: 48% versus RP: 41% (risk difference [RD], 90% CI: 7.3%, 1.2-13.4; relative risk [RR], 90% CI: 1.188, 1.033-1.366). Sensitivity analyses per central pathology review-ABP 980: 48%; RP: 42% (RD: 5.8%, -0.5 to 12.0; RR: 1.142, 0.993-1.312), with RD and RR falling within predefined equivalence margins. Similar to trastuzumab RP, KANJINTI™ is supplied as a sterile, lyophilized cake to be reconstituted with bacteriostatic water for injection (BWFI) for multiple-dose injection or sterile WFI for single use. Stability data support storage of reconstituted solution at 2-8°C (36-46°F), up to 28 days. Reconstituted solution can be diluted in infusion bags containing 0.9% saline and stored for up to 24 h prior to intravenous administration.

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Awake Proning: Current Evidence and Practical Considerations.

Publications

Awake Proning: Current Evidence and Practical Considerations.

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