tetano
Editor, Senior Moderator
Intensive Care Med
. 2023 Feb 23;1-11.
doi: 10.1007/s00134-023-06981-5. Online ahead of print.
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
Yaseen M Arabi[SUP] 1 2 3 [/SUP], Hasan M Al-Dorzi[SUP] 4 5 6 [/SUP], Sara Aldekhyl[SUP] 4 5 6 [/SUP], Saad Al Qahtani[SUP] 4 5 6 [/SUP], Sheryl Ann Abdukahil[SUP] 4 5 6 [/SUP], Eman Al Qasim[SUP] 4 5 6 [/SUP], Mohammad Khulaif Al Harbi[SUP] 5 6 7 [/SUP], Ayman Kharaba[SUP] 8 [/SUP], Talal Albrahim[SUP] 9 [/SUP], Mohammed S Alshahrani[SUP] 10 [/SUP], Abdulrahman A Al-Fares[SUP] 11 [/SUP], Ali Al Bshabshe[SUP] 12 [/SUP], Ahmed Mady[SUP] 13 14 [/SUP], Zainab Al Duhailib[SUP] 15 16 [/SUP], Haifa Algethamy[SUP] 17 [/SUP], Jesna Jose[SUP] 4 6 18 [/SUP], Mohammed Al Mutairi[SUP] 5 6 19 [/SUP], Omar Al Zumai[SUP] 5 6 19 [/SUP], Hussain Al Haji[SUP] 5 6 19 [/SUP], Ahmed Alaqeily[SUP] 5 6 19 [/SUP], Wedyan Al Wehaibi[SUP] 4 5 6 [/SUP], Zohair Al Aseri[SUP] 20 [/SUP], Awad Al-Omari[SUP] 16 21 [/SUP], Haytham Tlayjeh[SUP] 4 5 6 [/SUP], Abdulaziz Al-Dawood[SUP] 4 5 6 [/SUP]; Saudi Critical Care Trials Group
Collaborators, Affiliations
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.
. 2023 Feb 23;1-11.
doi: 10.1007/s00134-023-06981-5. Online ahead of print.
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
Yaseen M Arabi[SUP] 1 2 3 [/SUP], Hasan M Al-Dorzi[SUP] 4 5 6 [/SUP], Sara Aldekhyl[SUP] 4 5 6 [/SUP], Saad Al Qahtani[SUP] 4 5 6 [/SUP], Sheryl Ann Abdukahil[SUP] 4 5 6 [/SUP], Eman Al Qasim[SUP] 4 5 6 [/SUP], Mohammad Khulaif Al Harbi[SUP] 5 6 7 [/SUP], Ayman Kharaba[SUP] 8 [/SUP], Talal Albrahim[SUP] 9 [/SUP], Mohammed S Alshahrani[SUP] 10 [/SUP], Abdulrahman A Al-Fares[SUP] 11 [/SUP], Ali Al Bshabshe[SUP] 12 [/SUP], Ahmed Mady[SUP] 13 14 [/SUP], Zainab Al Duhailib[SUP] 15 16 [/SUP], Haifa Algethamy[SUP] 17 [/SUP], Jesna Jose[SUP] 4 6 18 [/SUP], Mohammed Al Mutairi[SUP] 5 6 19 [/SUP], Omar Al Zumai[SUP] 5 6 19 [/SUP], Hussain Al Haji[SUP] 5 6 19 [/SUP], Ahmed Alaqeily[SUP] 5 6 19 [/SUP], Wedyan Al Wehaibi[SUP] 4 5 6 [/SUP], Zohair Al Aseri[SUP] 20 [/SUP], Awad Al-Omari[SUP] 16 21 [/SUP], Haytham Tlayjeh[SUP] 4 5 6 [/SUP], Abdulaziz Al-Dawood[SUP] 4 5 6 [/SUP]; Saudi Critical Care Trials Group
Collaborators, Affiliations
- PMID: 36820878
- PMCID: PMC9947895
- DOI: 10.1007/s00134-023-06981-5
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.