Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial
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 patien...
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| Format: | Article |
| Language: | English |
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BMC
2023-05-01
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| Series: | Journal of Intensive Care |
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| Online Access: | https://doi.org/10.1186/s40560-023-00669-0 |
| _version_ | 1827943545846104064 |
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| author | Teresa Michi Chiara Mattana Luca S. Menga Maria Grazia Bocci Melania Cesarano Tommaso Rosà Maria Rosaria Gualano Jonathan Montomoli Savino Spadaro Matteo Tosato Elisabetta Rota Francesco Landi Salvatore L. Cutuli Eloisa S. Tanzarella Gabriele Pintaudi Edoardo Piervincenzi Giuseppe Bello Tommaso Tonetti Paola Rucci Gennaro De Pascale Salvatore M. Maggiore Domenico Luca Grieco Giorgio Conti Massimo Antonelli for the Gemelli COVID-ICU study group |
| author_facet | Teresa Michi Chiara Mattana Luca S. Menga Maria Grazia Bocci Melania Cesarano Tommaso Rosà Maria Rosaria Gualano Jonathan Montomoli Savino Spadaro Matteo Tosato Elisabetta Rota Francesco Landi Salvatore L. Cutuli Eloisa S. Tanzarella Gabriele Pintaudi Edoardo Piervincenzi Giuseppe Bello Tommaso Tonetti Paola Rucci Gennaro De Pascale Salvatore M. Maggiore Domenico Luca Grieco Giorgio Conti Massimo Antonelli for the Gemelli COVID-ICU study group |
| author_sort | Teresa Michi |
| collection | DOAJ |
| description | 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 |
| first_indexed | 2024-03-13T10:17:03Z |
| format | Article |
| id | doaj.art-af4603919fc24955b87e9e688943ff75 |
| institution | Directory Open Access Journal |
| issn | 2052-0492 |
| language | English |
| last_indexed | 2024-03-13T10:17:03Z |
| publishDate | 2023-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Intensive Care |
| spelling | doaj.art-af4603919fc24955b87e9e688943ff752023-05-21T11:09:58ZengBMCJournal of Intensive Care2052-04922023-05-0111111410.1186/s40560-023-00669-0Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trialTeresa Michi0Chiara Mattana1Luca S. Menga2Maria Grazia Bocci3Melania Cesarano4Tommaso Rosà5Maria Rosaria Gualano6Jonathan Montomoli7Savino Spadaro8Matteo Tosato9Elisabetta Rota10Francesco Landi11Salvatore L. Cutuli12Eloisa S. Tanzarella13Gabriele Pintaudi14Edoardo Piervincenzi15Giuseppe Bello16Tommaso Tonetti17Paola Rucci18Gennaro De Pascale19Salvatore M. Maggiore20Domenico Luca Grieco21Giorgio Conti22Massimo Antonelli23for the Gemelli COVID-ICU study groupDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Hygiene and Public Health, UniCamillus UniversityDepartment of Anaesthesia and Intensive Care, Infermi HospitalDepartment of Morphology, Surgery and Experimental Medicine, Azienda Ospedaliera-Universitaria Arcispedale Sant’Anna, University of FerraraGeriatrics Department, Fondazione Policlinico Universitario A. Gemelli IRCCSGeriatrics Department, Fondazione Policlinico Universitario A. Gemelli IRCCSGeriatrics Department, Fondazione Policlinico Universitario A. Gemelli IRCCSDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Medical and Surgical Sciences, Anesthesia and Intensive Care Medicine, Alma Mater Studiorum, Policlinico Di Sant’Orsola, Università Di BolognaDepartment of Biomedical and Neuromotor Science, Alma Mater Studiorum-Università Di BolognaDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Anesthesiology, Critical Care Medicine and Emergency, SS. Annunziata HospitalDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoDepartment of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, L.Go F. VitoAbstract 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, 2020https://doi.org/10.1186/s40560-023-00669-0COVID-19Noninvasive ventilationHelmetHigh-flow nasal oxygenAcute respiratory failurePatient self-inflicted lung injury (P-SILI) |
| spellingShingle | Teresa Michi Chiara Mattana Luca S. Menga Maria Grazia Bocci Melania Cesarano Tommaso Rosà Maria Rosaria Gualano Jonathan Montomoli Savino Spadaro Matteo Tosato Elisabetta Rota Francesco Landi Salvatore L. Cutuli Eloisa S. Tanzarella Gabriele Pintaudi Edoardo Piervincenzi Giuseppe Bello Tommaso Tonetti Paola Rucci Gennaro De Pascale Salvatore M. Maggiore Domenico Luca Grieco Giorgio Conti Massimo Antonelli for the Gemelli COVID-ICU study group Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial Journal of Intensive Care COVID-19 Noninvasive ventilation Helmet High-flow nasal oxygen Acute respiratory failure Patient self-inflicted lung injury (P-SILI) |
| title | Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial |
| title_full | Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial |
| title_fullStr | Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial |
| title_full_unstemmed | Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial |
| title_short | Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial |
| title_sort | long term outcome of covid 19 patients treated with helmet noninvasive ventilation vs high flow nasal oxygen a randomized trial |
| topic | COVID-19 Noninvasive ventilation Helmet High-flow nasal oxygen Acute respiratory failure Patient self-inflicted lung injury (P-SILI) |
| url | https://doi.org/10.1186/s40560-023-00669-0 |
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