Contemporary Clinical Trials Communications (Jun 2024)

A randomised clinical trial of awake prone positioning in COVID-19 suspects with acute hypoxemic respiratory failure

  • Tim R.E. Harris,
  • Zain A. Bhutta,
  • Isma Qureshi,
  • Nadir Kharma,
  • Tasleem Raza,
  • Ali Ait Hssain,
  • Ankush Suresh Pathare,
  • Ashwin D'Silva,
  • Mohamad Yahya Khatib,
  • Mohamed Gafar Hussein Mohamedali,
  • Ignacio Miguel Gomez Macineira,
  • Victor Ramon Garcia Hernandez,
  • Jorge Rosales Garcia,
  • Stephen H. Thomas,
  • Sameer A. Pathan

Journal volume & issue
Vol. 39
p. 101295

Abstract

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Background: Awake prone position (APP) has been reported to improve oxygenation in patients with COVID-19 disease and to reduce the requirement for invasive mechanical ventilation for patients requiring support with high flow nasal cannula. There is conflicting data for patients requiring lower-level oxygen support. Research question: Does APP reduce escalation of oxygen support in COVID-19 patients requiring supplementary oxygen?The primary outcome was defined as an escalation of oxygen support from simple supplementary oxygen (NP, HM, NRB) to NIV (CPAP or BiPAP), HFNC or IMV; OR from NIV (CPAP or BiPAP) or HFNC to IMV by day30. Study design: Two center, prospective, non-blind, randomised controlled trial. Patients with confirmed or suspected COVID-19 pneumonia requiring ≥ 5 liters/min oxygen to maintain saturations ≥ 94 % were randomised to either APP or control group. The APP group received a 3-h APP session three times per day for three days. Results: Between 9 May and July 13, 2021, 89 adults were screened and 61 enrolled, 31 to awake prone position and 30 controls. There was no difference in the primary outcome, 7 (22.6 %) patients randomised to APP and 9 (30.0 %) controls required escalation of oxygen support (OR 0.68 (0.22–2.14), P = 0.51). There were no differences in any secondary outcomes, in APP did not improve oxygenation. Interpretation: In COVID-19 patients, the use of APP did not prevent escalation of oxygen support from supplementary to invasive or non-invasive ventilation or improve patient respiratory physiology. Trial registration: NCT04853979 (clinicaltrials.gov).

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