Helmet CPAP Versus Oxygen Therapy in Hypoxemic Acute Respiratory Failure: A Meta-analysis of Randomized Controlled Trials

Luo, Yuqi; Yan, L.‐X.; Li, Yun; Zhou, Luqian; Zhu, Zhe; Chen, Xin

doi:10.1016/j.chest.2016.02.170

Cited by 3 publications

(1 citation statement)

References 24 publications

(44 reference statements)

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“…(17) A meta-analysis of four RCTs (377 patients) showed that helmet NIV significantly increased the PaO 2 /FiO 2 (+73.4; 95% CI, 43.9-102.9) and decreased the arterial carbon dioxide levels, intubation rate (relative risk, 0.21; 95% CI, 0.11- 0.40) and in-hospital mortality rate (relative risk, 0.22; 95% CI, 0.09-0.50) compared to standard oxygen therapy. (18) A network meta-analysis of 25 studies that included 3804 patients with acute hypoxemic respiratory failure for reasons other than COVID-19 found significantly lower intubation risks with helmet NIV compared with standard oxygen therapy. (7) The advantages of helmet NIV over other oxygen support modalities are thought to be more prominent in patients with COVID-19.…”

Section: Discussionmentioning

confidence: 99%

Statistical Analysis Plan for the Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID) Randomized Controlled Trial

Arabi

Tlayjeh

Aldekhyl

et al. 2021

Preprint

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Background and objective Noninvasive respiratory support is frequently needed for patients with acute hypoxemic respiratory failure due to coronavirus disease 19 (COVID-19). Helmet noninvasive ventilation having multiple advantages over other support modalities but data about effectiveness are limited. Methods In this multicenter randomized trial of helmet non-invasive ventilation for COVID-19 patients (Helmet-COVID), 320 adult ICU patients with suspected or confirmed COVID-19 and acute hypoxemic respiratory failure (with a ratio of arterial oxygen partial pressure to fraction (percent) of inspired oxygen (PaO2/FiO2) <200 despite supplemental oxygen with a partial/non-rebreathing mask at a flow rate >10 L/min or above) will be randomized to helmet-noninvasive ventilation with usual care or usual care alone. The primary outcome is death from any cause within 28 days after randomization. The trial has 80% power to detect a 15% absolute risk reduction from 40% to 25%. Conclusion Consistent with international guidelines, we developed a detailed plan to guide the analysis of the Helmet-COVID trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes to facilitate unbiased analyses of clinical data.

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Section: Discussionmentioning

confidence: 99%

Statistical Analysis Plan for the Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID) Randomized Controlled Trial

Arabi

Tlayjeh

Aldekhyl

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

Helmet noninvasive ventilation for COVID-19 patients “Helmet-COVID”: study protocol for a multicenter randomized controlled trial

Arabi

Tlayjeh

Aldekhyl

et al. 2021

Preprint

View full text Add to dashboard Cite

IntroductionNoninvasive ventilation delivered by helmet is has been used for respiratory support of patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia. The aim of this study is to compare helmet noninvasive ventilation with usual care versus usual care alone to reduce the mortality.Methods and analysisThis is a multicenter, pragmatic, parallel, randomized controlled trial that compares helmet noninvasive ventilation with usual care to usual care alone in 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness.Ethics and disseminationApprovals are obtained from the Institutional Review Boards (IRBs) of each participating institution. Our findings will be published in peer-review journals and presented at relevant conferences and meetings.Trial registration numberNCT04477668 registered on July 20, 2020Article SummaryStrengths and limitations of this studyThis trial compares helmet NIV to usual care for respiratory support of patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.The trial is a multi-center, pragmatic, parallel randomized controlled trial.The main limitation is the unblinded design due to the nature of the intervention.

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Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial

et al. 2021

View full text Add to dashboard Cite

IntroductionNon-invasive ventilation (NIV) delivered by helmet has been used for respiratory support of patients with acute hypoxaemic respiratory failure due to COVID-19 pneumonia. The aim of this study was to compare helmet NIV with usual care versus usual care alone to reduce mortality.Methods and analysisThis is a multicentre, pragmatic, parallel randomised controlled trial that compares helmet NIV with usual care to usual care alone in a 1:1 ratio. A total of 320 patients will be enrolled in this study. The primary outcome is 28-day all-cause mortality. The primary outcome will be compared between the two study groups in the intention-to-treat and per-protocol cohorts. An interim analysis will be conducted for both safety and effectiveness.Ethics and disseminationApprovals are obtained from the institutional review boards of each participating institution. Our findings will be published in peer-reviewed journals and presented at relevant conferences and meetings.Trial registration numberNCT04477668.

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Helmet CPAP Versus Oxygen Therapy in Hypoxemic Acute Respiratory Failure: A Meta-analysis of Randomized Controlled Trials

Cited by 3 publications

References 24 publications

Statistical Analysis Plan for the Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID) Randomized Controlled Trial

Statistical Analysis Plan for the Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID) Randomized Controlled Trial

Helmet noninvasive ventilation for COVID-19 patients “Helmet-COVID”: study protocol for a multicenter randomized controlled trial

Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial

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