Long-term outcomes of patients with COVID-19 treated with helmet noninvasive ventilation or usual respiratory support: follow-up study of the Helmet-COVID randomized clinical trial

Abstract

Purpose: To evaluate whether helmet noninvasive ventilation compared to usual respiratory support reduces 180-day mortality and improves health-related quality of life (HRQoL) in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.

Methods: This is a pre-planned follow-up study of the Helmet-COVID trial. In this multicenter, randomized clinical trial, adults with acute hypoxemic respiratory failure (n = 320) due to coronavirus disease 2019 (COVID-19) were randomized to receive helmet noninvasive ventilation or usual respiratory support. The modified intention-to-treat population consisted of all enrolled patients except three who were lost at follow-up. The study outcomes were 180-day mortality, EuroQoL (EQ)-5D-5L index values, and EQ-visual analog scale (EQ-VAS). In the modified intention-to-treat analysis, non-survivors were assigned a value of 0 for EQ-5D-5L and EQ-VAS.

Results: Within 180 days, 63/159 patients (39.6%) died in the helmet noninvasive ventilation group compared to 65/158 patients (41.1%) in the usual respiratory support group (risk difference - 1.5% (95% confidence interval [CI] - 12.3, 9.3, p = 0.78). In the modified intention-to-treat analysis, patients in the helmet noninvasive ventilation and the usual respiratory support groups did not differ in EQ-5D-5L index values (median 0.68 [IQR 0.00, 1.00], compared to 0.67 [IQR 0.00, 1.00], median difference 0.00 [95% CI - 0.32, 0.32; p = 0.91]) or EQ-VAS scores (median 70 [IQR 0, 93], compared to 70 [IQR 0, 90], median difference 0.00 (95% CI - 31.92, 31.92; p = 0.55).

Conclusions: Helmet noninvasive ventilation did not reduce 180-day mortality or improve HRQoL compared to usual respiratory support among patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.

Trial registration: ClinicalTrials.gov NCT04477668.

Keywords: Acute hypoxemic respiratory failure; COVID-19; Helmet; High-flow nasal oxygen; Noninvasive ventilation; Quality of life.

Fig. 1

Kaplan–Meier time-to-event curves for mortality in the helmet noninvasive ventilation group and the usual respiratory support group in the modified intention-to-treat population. All patients were observed to event or 180 days

Fig. 2

A, B and C Comparisons of EQ-5D-5L index values, EQ-VAS and EQ-5D-5L dimension levels between patients in the helmet noninvasive ventilation and usual respiratory support groups; none of the comparisons were statistically significantly different between the two groups. A and B Distribution of the EQ-5D-5L index values and EQ-VAS as horizontally stacked proportions in patients assigned to helmet noninvasive ventilation and usual respiratory support in the modified intention-to-treat population. C Distributions of individual EQ-5D-5L dimension levels in the HRQoL population in patients assigned to helmet noninvasive ventilation and usual respiratory support (see also Table S6, Online Supplement). D, E and F Comparisons of EQ-5D-5L index values, EQ-VAS and EQ-5D-5L dimension levels between patients who were intubated and those who were not intubated; all comparisons were statistically significantly different between the two groups. D and E Distribution of the EQ-5D-5L index values and EQ-VAS as horizontally stacked proportions in patients who were intubated and those who were not intubated in the modified intention-to-treat population. F Distributions of individual EQ-5D-5L dimension levels in patients who were intubated and those who were not in the HRQoL population (see also Tables S8 and S9, Online Supplement)