Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients.
Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients: a Multicentric, National, Observational, Retrospective Study.
COVID-19 is an infectious disease caused by SARS-CoV2 virus. COVID-19 patients can develop a severe disease that can lead to hypoxic respiratory failure and acute respiratory distress syndrome (ARDS). Severe patients can require access to intensive care unit (ICU). Early rehabilitation is known to be effective in critically ill patients and in ARDS.
Early rehabilitation is known to be effective in critically ill subjects. The role of physiotherapy in severe COVID-19 patients is still unclear and few guidelines have been proposed so far. Aim of this study is to assess efficacy of early rehabilitation for severe ICU-admitted COVID-19 patients as compared to a group that did not received physiotherapy treatment in ICU.
調査の概要
詳細な説明
COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which emerged in China in December 2019 and in Italy in February 2020. A large proportion of infected people have mild clinical manifestations, whereas >10% develop a severe disease, which could evolve into acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) requiring intensive care unit (ICU) admission. A high proportion of ICU patients need invasive mechanical ventilation (IMV) and about 50% of the ICU-admitted patients die. The median age of ICU COVID-19 patients was <65 years and the mortality in patients aged <63 years ranges from 15 to 20%.
Early rehabilitation is safe and effective in critically ill patients and, in patients with ARDS, it helps to reduce the functional impairment due to the prolonged stay in ICU. Preliminary data suggest the implementation of early and active mobilization programs, as well as airway clearance, for patients with severe forms of COVID-19. To date, the role of respiratory physiotherapy in severe COVID-19 patients is still unclear.
Aim of this study is to assess efficacy of early rehabilitation for severe ICU-admitted COVID-19 patients as compared to a group that did not recevied physiotherapy treatment in ICU. Physiotherapy efficacy is evaluated in terms of ventilator free days (VFD) during the first 30 days after neuromuscular blockade stop.
Moreover, duration of ICU stay and patient functional status at ICU discharge will be evaluated.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Genova、イタリア
- Ospedale San Martino
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Milano、イタリア、20122
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Trento、イタリア
- APSS Provincia Autonoma di Trento Ospedale Santa Chiara
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Milan
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Milano、Milan、イタリア
- ASST Grande Ospedale Metropolitano Niguarda
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Having laboratory confirmed COVID-19 pneumonia
- Developed hypoxemic acute respiratory failure (hARF) requiring access to ICU
- Treated by physiotherapists during the ICU stay
- Stopped the neuromuscular blokade treatment
Exclusion Criteria:
- Previuos cognitive deficit (Mini menatal state examination <20)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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Control
COVID-19 ICU-admitted patients that did not received physiotherapy interventions during ICU stay.
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Physiotherapy
COVID-19 ICU-admitted patients that received physiotherapy interventions during ICU stay.
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Respiratory physiotherapy included:
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Ventilator-free days (VFD) and alive at day 28
時間枠：Up to 28 days after neuromuscular blokade stop
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To determine if early physiotherapy, as compared to no physiotherapy treatment, increases the number of ventilator-free days (VFD) and alive at day 28 in severe COVID-19 ICU-admitted patients.
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Up to 28 days after neuromuscular blokade stop
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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ICU stay duration
時間枠：From ICU admission to ICU discharge; up to 60 days.
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Mean days of ICU stay
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From ICU admission to ICU discharge; up to 60 days.
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PaO2/FiO2
時間枠：At ICU discharge; up to 60 days
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Mean measure of PaO2/FiO2
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At ICU discharge; up to 60 days
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ICU survival rate
時間枠：From ICU admission until date of death from any cause, during ICU stay; up to 100 days.
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Number of patients that survived ICU stay
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From ICU admission until date of death from any cause, during ICU stay; up to 100 days.
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hospital survival rate
時間枠：From ICU admission until date of death from any cause, during hospitalization
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Number of patients that survived hospitalization
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From ICU admission until date of death from any cause, during hospitalization
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90 days survival rate
時間枠：From ICU admission until date of death from any cause, assessed up to 90 days after neuromuscular blokade removal
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Number of patients that survived during 90 days after neuromuscular blokade stop
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From ICU admission until date of death from any cause, assessed up to 90 days after neuromuscular blokade removal
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:
- Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
- Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
- Lazzeri M, Lanza A, Bellini R, Bellofiore A, Cecchetto S, Colombo A, D'Abrosca F, Del Monaco C, Gaudiello G, Paneroni M, Privitera E, Retucci M, Rossi V, Santambrogio M, Sommariva M, Frigerio P. Respiratory physiotherapy in patients with COVID-19 infection in acute setting: a Position Paper of the Italian Association of Respiratory Physiotherapists (ARIR). Monaldi Arch Chest Dis. 2020 Mar 26;90(1). doi: 10.4081/monaldi.2020.1285.
- Kim RY, Murphy TE, Doyle M, Pulaski C, Singh M, Tsang S, Wicker D, Pisani MA, Connors GR, Ferrante LE. Factors Associated With Discharge Home Among Medical ICU Patients in an Early Mobilization Program. Crit Care Explor. 2019 Nov 11;1(11):e0060. doi: 10.1097/CCE.0000000000000060. eCollection 2019 Nov.
- Privitera E, Gambazza S, Rossi V, Santambrogio M, Binda F, Tarello D, Caiffa S, Turrin V, Casagrande C, Battaglini D, Panigada M, Fumagalli R, Pelosi P, Grasselli G. Association of ventilator-free days with respiratory physiotherapy in critically ill patients with Coronavirus Disease 2019 (COVID-19) during the first pandemic wave. A propensity score-weighted analysis. Front Med (Lausanne). 2022 Sep 12;9:994900. doi: 10.3389/fmed.2022.994900. eCollection 2022.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FISIO-UTI-COVID
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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Early physiotherapyの臨床試験
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University of FloridaPerformance Health引きこもった
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Florida International UniversityNational Institute on Minority Health and Health Disparities (NIMHD)募集
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Brigham and Women's HospitalBiofourmis Inc.完了
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Bruno RhinerUniversity of Arkansas; West Virginia University終了しました
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University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of Medicine; National Institute of Chemistry, Ljubljana, Slovenia と他の協力者完了