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Dyspnoea and clinical outcome in critically ill patients receiving noninvasive support for COVID-19 respiratory failure: post hoc analysis of a randomised clinical trial

Luca S. Menga, Domenico Luca Grieco, Tommaso Rosà, Melania Cesarano, Luca Delle Cese, Cecilia Berardi, Gabriele Pintaudi, Eloisa Sofia Tanzarella, Salvatore L. Cutuli, Gennaro De Pascale, Salvatore Maurizio Maggiore, Massimo Antonelli for the COVID-ICU Gemelli study group
ERJ Open Research 2021 7: 00418-2021; DOI: 10.1183/23120541.00418-2021
Luca S. Menga
1Dept of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
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Domenico Luca Grieco
1Dept of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
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  • ORCID record for Domenico Luca Grieco
  • For correspondence: dlgrieco@outlook.it
Tommaso Rosà
1Dept of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
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Melania Cesarano
1Dept of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
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Luca Delle Cese
1Dept of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
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Cecilia Berardi
1Dept of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
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Gabriele Pintaudi
1Dept of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
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Eloisa Sofia Tanzarella
1Dept of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
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Salvatore L. Cutuli
1Dept of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
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Gennaro De Pascale
1Dept of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
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Salvatore Maurizio Maggiore
3University Dept of Innovative Technologies in Medicine and Dentistry, Gabriele d'Annunzio University of Chieti-Pescara, Chieti, Italy
4Dept of Anesthesiology, Critical Care Medicine and Emergency, S.S. Annunziata Hospital, Chieti, Italy
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Massimo Antonelli
1Dept of Emergency, Intensive Care Medicine and Anesthesia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
2Istituto di Anestesiologia e Rianimazione, Università Cattolica del Sacro Cuore, Rome, Italy
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Tables

  • TABLE 1

    Characteristics at inclusion and study outcomes, according to study group

    Moderate-to-severe dyspnoea (n=52)Mild or no dyspnoea (n=57)Adjusted mean difference (95% CI)OR (95% CI)p-value
    Demographics
     Age, years61 (53–70)65 (58–71)0.15
     Female sex9 (17)12 (21)0.64
     Male sex43 (83)45 (79)0.64
     Body mass index, kg·m−228 (26–30)27 (25–30)0.37
     Respiratory rate at enrolment, breaths per min28 (24–33)27 (23–30)0.13
     Device-related discomfort at enrolment#2 (0–5)0 (0–0)<0.001
     Arterial blood gases at enrolment
      PaO2/FIO2 ratio, mmHg97 (82–117)110 (83–132)0.12
      PaO2, mmHg60 (54–74)66 (55–75)0.71
      pH7.46 (7.45–7.49)7.46 (7.45–7.48)0.95
      PaCO2, mmHg34 (31–37)34 (32–37)0.50
     Allocated treatment¶
      Helmet noninvasive ventilation27 (52)27 (47)0.70
      High-flow oxygen25 (48)30 (53)0.70
    Outcomes
     Respiratory support+-free days at 28 days12 (0–23)21 (4–25)−5 (−8– −1)0.008
     Intubation within 28 days from enrolment27 (52)17 (30)3.8 (1.5–9.9)0.006
     Invasive ventilation-free days at 28 days20 (4–28)28 (16–28)−5 (−9– −1)0.02
     Invasive ventilation free days at 60 days52 (11–60)60 (48–60)−9 (−17– −1)0.03
     28-day mortality10 (19)8 (14)1.8 (0.6–5)0.29
     60-day mortality14 (27)11 (19)2 (0.8–5.5)0.16
     Intensive care unit mortality15 (29)10 (17)2.8 (1–7.7)0.05
     Hospital mortality§16 (31)11 (19)2.6 (1–7)0.05
     Length of stay in the intensive care unit, days12 (6–29)7 (4–12)6 (0–6)0.05
     Length of stay in the hospital, days24 (16–41)18 (12–29)8 (0–15)0.04

    Data are presented as median (interquartile range) or n (%), unless otherwise stated. There were no missing data among the two groups. Mean difference and odds ratio were adjusted for Simplified Acute Physiology Score II, allocated treatment (high-flow nasal oxygen or helmet noninvasive ventilation) and arterial oxygen tension (PaO2)/inspiratory oxygen fraction (FIO2) ratio on intensive care unit admission. For non-normal quantitative variables, comparison between groups was performed with Mann–Whitney test. Comparison between groups for qualitative variables were performed with the Chi-squared test or the Fisher's exact test, as appropriate in agreement with tests assumptions. All the calculations were unadjusted. PaCO2: arterial carbon dioxide tension. #: discomfort was assessed through visual analogue scales adapted for intensive care unit patients, ranging from 0 to 10; ¶: advanced respiratory support interface used in the first 48 h; +: invasive or noninvasive mechanical ventilation, high-flow nasal oxygen; §: one patient was discharged from hospital but died upon readmission.

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    Dyspnoea and clinical outcome in critically ill patients receiving noninvasive support for COVID-19 respiratory failure: post hoc analysis of a randomised clinical trial
    Luca S. Menga, Domenico Luca Grieco, Tommaso Rosà, Melania Cesarano, Luca Delle Cese, Cecilia Berardi, Gabriele Pintaudi, Eloisa Sofia Tanzarella, Salvatore L. Cutuli, Gennaro De Pascale, Salvatore Maurizio Maggiore, Massimo Antonelli
    ERJ Open Research Oct 2021, 7 (4) 00418-2021; DOI: 10.1183/23120541.00418-2021

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    Dyspnoea and clinical outcome in critically ill patients receiving noninvasive support for COVID-19 respiratory failure: post hoc analysis of a randomised clinical trial
    Luca S. Menga, Domenico Luca Grieco, Tommaso Rosà, Melania Cesarano, Luca Delle Cese, Cecilia Berardi, Gabriele Pintaudi, Eloisa Sofia Tanzarella, Salvatore L. Cutuli, Gennaro De Pascale, Salvatore Maurizio Maggiore, Massimo Antonelli
    ERJ Open Research Oct 2021, 7 (4) 00418-2021; DOI: 10.1183/23120541.00418-2021
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