- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05067907
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Genova, Italien
- Ospedale San Martino
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Milano, Italien, 20122
- Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
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Trento, Italien
- APSS Provincia Autonoma di Trento Ospedale Santa Chiara
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Milan
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Milano, Milan, Italien
- ASST Grande Ospedale Metropolitano Niguarda
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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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:
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Ventilator-free days (VFD) and alive at day 28
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
ICU stay duration
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Coronavirusinfektioner
- Coronaviridae-infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Luftvägsinfektioner
- Luftvägssjukdomar
- Andningsstörningar
- Lunginflammation, Viral
- Lunginflammation
- Lungsjukdomar
- Spädbarn, nyfödda, sjukdomar
- Lungskada
- Spädbarn, för tidigt födda, Sjukdomar
- Covid-19
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, nyfödd
- Akut lungskada
Andra studie-ID-nummer
- FISIO-UTI-COVID
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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