Does awake prone positioning prevent the use of mechanical respiratory support or death in COVID-19 patients on standard oxygen therapy hospitalised in general wards? A multicentre randomised controlled trial: the PROVID-19 protocol

Nay, Mai-Anh; Planquette, Benjamin; Perrin, Christophe; CLÉMENT, Jérémy; Plantier, Laurent; Sève, Aymeric; Druelle, Sylvie; Morrier, Marine; LAINÉ, Jean-Baptiste; Colombain, L.; Corvaisier, Grégory; Bizien, Nicolas; Pouget-Abadie, X.; Bigot, A.; Bernard, Louis; Nyamankolly, Elsa; Fossat, Guillaume; Boulain, Thierry

doi:10.1136/bmjopen-2021-060320

Cited by 4 publications

(5 citation statements)

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“…The published statistical plan, which planned to use a Mantel-Haenzel chi-squared test to analyse the primary outcome, was modi ed (see Additional le 1 and Additional le 2, page 3 for details,): (24) The relative risk of NIV or intubation or death within 28 days of enrollment (primary outcome) between randomisation groups was estimated by adjusted odds ratios (aOR) and 95% con dence interval (95% CIs) obtained by a multivariable mixed-effect logistic regression model, with the recruiting ward as a random effect and study intervention and strati cation variables (SpO 2 and body mass index) as xedeffect variables. Interaction terms between the strati cation variables and the intervention were retained if they showed a signi cant statistical link with the frequency of treatment failure.…”

Section: Discussionmentioning

confidence: 99%

“…Given scarce published data (15,16,19) at the time we launched the trial, the sample size calculation was highly speculative and was revised in November 2021 (24) because of the decrease in SARS-CoV-2 infection rate in France at that time. We assumed that the treatment failure rate would be 4% in the intervention group and 14% in the usual care group, with lost to follow-up < 2%.…”

Section: Sample Sizementioning

confidence: 99%

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WITHDRAWN: Prone-position versus usual care in hypoxemic COVID-19 patients in medical wards: a randomized controlled trial

Nay

Hindre

Perrin

et al. 2023

Preprint

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Background: Benefit of early awake prone positioning (PP) for COVID-19 patients hospitalised in medical wards and who need oxygen therapy remains to be demonstrated. The question was considered at the time of COVID-19 pandemic to avoid overloading the intensive care units. We aimed to determine whether PP plus usual care could reduce the rate of non-invasive ventilation (NIV) or intubation or death as compared with usual care alone. Methods: In this multicentre randomised clinical trial, 268 patients were randomly assigned to awake PP plus usual care (N=135) or usual care alone (N=132). The primary outcome was the proportion of patients who underwent NIV or intubation or died within 28 days. Mains secondary outcomes included the rates of NIV, of intubation or death, within 28 days. Results: The proportion of NIV or intubation or death within 28 days was 14.1% (19/135) in the PP group and 12.9% (17/132) in the usual care group (odds ratio adjusted for stratification [aOR] 0.43; 95% confidence interval [CI] 0.14 to 1.35). The probability of intubation, or intubation or death (secondary outcomes) was reduced in the PP versus usual care group (aOR 0.11; 95%CI 0.01 to 0.89 and aOR 0.09; 95%CI 0.01 to 0.76, respectively) in the whole study population and in the prespecified subgroup of patients with SpO2 ≥95% on inclusion (aOR 0.11; 95%CI 0.01 to 0.90, and aOR 0.09; 95%CI 0.03 to 0.27, respectively). Conclusions: Awake PP plus usual care in COVID-19 patients in medical wards did not decrease the need for NIV or intubation or death. Trial registration: ClinicalTrials.gov Identifier: NCT04363463. Registered 27 April 2020.

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Section: Discussionmentioning

confidence: 99%

Section: Sample Sizementioning

confidence: 99%

WITHDRAWN: Prone-position versus usual care in hypoxemic COVID-19 patients in medical wards: a randomized controlled trial

Nay

Hindre

Perrin

et al. 2023

Preprint

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“…Given scarce published data [ 15 , 16 , 19 ] at the time we launched the trial, the sample size calculation was highly speculative and was revised in November 2021 [ 27 ] because of the decrease in SARS-CoV-2 infection rate in France at that time. We assumed that the treatment failure rate would be 4% in the intervention group and 14% in the usual care group, with lost to follow-up < 2%.…”

Section: Methodsmentioning

confidence: 99%

“…The published statistical plan, which planned to use a Mantel–Haenszel Chi-squared test to analyse the primary outcome, was modified (see Additional files 1 and 2 , page 3 for details) [ 27 ]. The relative risk of NIV or intubation or death within 28 days of enrolment (primary outcome) between randomisation groups was estimated by adjusted odds ratios (aOR) and 95% confidence interval (95% CI) obtained by a multivariable mixed-effect logistic regression model, with the recruiting ward as a random effect and study intervention and stratification variables (SpO 2 and body mass index) as fixed-effect variables.…”

Section: Methodsmentioning

confidence: 99%

Prone position versus usual care in hypoxemic COVID-19 patients in medical wards: a randomised controlled trial

et al. 2023

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Background Benefit of early awake prone positioning for COVID-19 patients hospitalised in medical wards and who need oxygen therapy remains to be demonstrated. The question was considered at the time of COVID-19 pandemic to avoid overloading the intensive care units. We aimed to determine whether prone position plus usual care could reduce the rate of non-invasive ventilation (NIV) or intubation or death as compared to usual care alone. Methods In this multicentre randomised clinical trial, 268 patients were randomly assigned to awake prone position plus usual care (N = 135) or usual care alone (N = 132). The primary outcome was the proportion of patients who underwent NIV or intubation or died within 28 days. Main secondary outcomes included the rates of NIV, of intubation or death, within 28 days. Results Median time spent each day in the prone position within 72 h of randomisation was 90 min (IQR 30–133). The proportion of NIV or intubation or death within 28 days was 14.1% (19/135) in the prone position group and 12.9% (17/132) in the usual care group [odds ratio adjusted for stratification (aOR) 0.43; 95% confidence interval (CI) 0.14–1.35]. The probability of intubation, or intubation or death (secondary outcomes) was lower in the prone position group than in the usual care group (aOR 0.11; 95% CI 0.01–0.89 and aOR 0.09; 95% CI 0.01–0.76, respectively) in the whole study population and in the prespecified subgroup of patients with SpO2 ≥ 95% on inclusion (aOR 0.11; 95% CI 0.01–0.90, and aOR 0.09; 95% CI 0.03–0.27, respectively). Conclusions Awake prone position plus usual care in COVID-19 patients in medical wards did not decrease the composite outcome of need for NIV or intubation or death. Trial registration ClinicalTrials.gov Identifier: NCT04363463. Registered 27 April 2020.

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“…Whilst APP may require few resources it does require adequately trained staff to respond to signals of concern and the infrastructure to act upon this. The PROVID-19 protocol aims to look at the implementation of APP on general medical wards and will provide information on safety outside of a critical care setting 39 .…”

Section: Future Research Questionsmentioning

confidence: 99%

Awake Prone Positioning for Acute Hypoxaemic Respiratory Failure in COVID-19

Thorley

Graeme-Wilson

Curtis

2022

MRAJ

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Prone positioning has been demonstrated to significantly reduce mortality in invasively ventilated patients with moderate to severe acute respiratory distress syndrome through several physiological mechanisms, including optimization of ventilation and perfusion and a reduction in ventilator-associated lung injury. The marked increase of hospitalisation rates of patients with acute hypoxaemic respiratory failure during the COVID-19 pandemic, and associated strain on healthcare resources, led to interest in the use of prone positioning in conscious self-ventilating, or “awake”, patients, as an adjunct to the provision of oxygen therapy and respiratory support. The adoption of this technique was with the intent of reducing the likelihood of progressive respiratory failure and thus the need for invasive mechanical ventilation. In this review we summarize the background, physiological mechanisms and current evidence for the use of awake prone positioning in both COVID-19 related hypoxaemic respiratory failure and that attributed to other aetiologies. Whilst several studies note an improvement in respiratory parameters including oxygenation, the effect on clinically important outcomes such as rates of intubation and mortality remain unclear. The evidence base beyond COVID-19 related respiratory failure remains constrained and there is a paucity of evidence to help identify those most likely to benefit from this therapy. There remains no agreed consensus on how to implement awake prone positioning and significant variation exists in practice. Several clinical questions should be the focus for future research studies of this treatment modality including how to identify early responders and non-responders to therapy.

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Does awake prone positioning prevent the use of mechanical respiratory support or death in COVID-19 patients on standard oxygen therapy hospitalised in general wards? A multicentre randomised controlled trial: the PROVID-19 protocol

Cited by 4 publications

References 35 publications

WITHDRAWN: Prone-position versus usual care in hypoxemic COVID-19 patients in medical wards: a randomized controlled trial

WITHDRAWN: Prone-position versus usual care in hypoxemic COVID-19 patients in medical wards: a randomized controlled trial

Prone position versus usual care in hypoxemic COVID-19 patients in medical wards: a randomised controlled trial

Awake Prone Positioning for Acute Hypoxaemic Respiratory Failure in COVID-19

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