Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial
Authors: Michi Teresa , Mattana Chiara , Menga Luca S. , Bocci Maria Grazia , Cesarano Melania , Rosà Tommaso , Gualano Maria Rosaria , Montomoli Jonathan , Spadaro Savino , Tosato Matteo , Rota Elisabetta , Landi Francesco , Cutuli Salvatore L. , Tanzarella Eloisa S. , Pintaudi Gabriele , Piervincenzi Edoardo , Bello Giuseppe , Tonetti Tommaso , Rucci Paola , De Pascale Gennaro , Maggiore Salvatore M. , Grieco Domenico Luca , Conti Giorgio , Antonelli Massimo ,   for the Gemelli COVID-ICU study group, Maviglia Riccardo , Mercurio Giovanna , De Santis Paolo , Pennisi Mariano Alberto , Anzellotti Gian Marco , Torrini Flavia , Rubino Carlotta , Morena Tony C. , Gennenzi Veronica , Postorino Stefania , Vargas Joel , Filetici Nicoletta , Settanni Donatella , Durante Miriana , Cascarano Laura , Di Muro Mariangela , Scarascia Roberta , Bitondo Maria Maddalena , Murdolo Martina , Mele Alessandro , Silva Serena , Zaccone Carmelina , Pozzana Francesca , Maccaglia Alessio , Savino Martina , Potalivo Antonella , Ceccaroni Francesca , Scavone Angela , Lombardi Gianmarco , Bello Giuseppe , Montini Luca , Dell’Anna Antonio Maria , Volta Carlo Alberto , Ranieri Vito M. , Falò Giulia , Carelli Simone , Natalini Daniele , Berardi Cecilia , Delle Cese Luca , Vetrugno Luigi , Balzani Eleonora 
Published: May 2023

Abstract
Background
Long-term outcomes of patients treated with helmet noninvasive ventilation (NIV) are unknown: safety concerns regarding the risk of patient self-inflicted lung injury and delayed intubation exist when NIV is applied in hypoxemic patients. We assessed the 6-month outcome of patients who received helmet NIV or high-flow nasal oxygen for COVID-19 hypoxemic respiratory failure.

Methods
In this prespecified analysis of a randomized trial of helmet NIV versus high-flow nasal oxygen (HENIVOT), clinical status, physical performance (6-min-walking-test and 30-s chair stand test), respiratory function and quality of life (EuroQoL five dimensions five levels questionnaire, EuroQoL VAS, SF36 and Post-Traumatic Stress Disorder Checklist for the DSM) were evaluated 6 months after the enrollment.

Results
Among 80 patients who were alive, 71 (89%) completed the follow-up: 35 had received helmet NIV, 36 high-flow oxygen. There was no inter-group difference in any item concerning vital signs (N = 4), physical performance (N = 18), respiratory function (N = 27), quality of life (N = 21) and laboratory tests (N = 15). Arthralgia was significantly lower in the helmet group (16% vs. 55%, p = 0.002). Fifty-two percent of patients in helmet group vs. 63% of patients in high-flow group had diffusing capacity of the lungs for carbon monoxide < 80% of predicted (p = 0.44); 13% vs. 22% had forced vital capacity < 80% of predicted (p = 0.51). Both groups reported similar degree of pain (p = 0.81) and anxiety (p = 0.81) at the EQ-5D-5L test; the EQ-VAS score was similar in the two groups (p = 0.27). Compared to patients who successfully avoided invasive mechanical ventilation (54/71, 76%), intubated patients (17/71, 24%) had significantly worse pulmonary function (median diffusing capacity of the lungs for carbon monoxide 66% [Interquartile range: 47–77] of predicted vs. 80% [71–88], p = 0.005) and decreased quality of life (EQ-VAS: 70 [53–70] vs. 80 [70–83], p = 0.01).

Conclusions
In patients with COVID-19 hypoxemic respiratory failure, treatment with helmet NIV or high-flow oxygen yielded similar quality of life and functional outcome at 6 months. The need for invasive mechanical ventilation was associated with worse outcomes. These data indicate that helmet NIV, as applied in the HENIVOT trial, can be safely used in hypoxemic patients.
Trial registration Registered on clinicaltrials.gov NCT04502576 on August 6, 2020