Clinical trial NCT05067907: Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients.
Official title: Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients: a Multicentric, National, Observational, Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will study patients accessing acute hospital ICU with hypoxemic acute respiratory failure (hARF) due to laboratory confirmed COVID-19 pneumonia form March 1st to May 30th.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Ventilator-free days (VFD) and alive at day 28
timeFrame: Up to 28 days after neuromuscular blokade stop
Secondary outcomes:
measure: ICU stay duration
timeFrame: From ICU admission to ICU discharge; up to 60 days.
measure: PaO2/FiO2
timeFrame: At ICU discharge; up to 60 days
measure: ICU survival rate
timeFrame: From ICU admission until date of death from any cause, during ICU stay; up to 100 days.
measure: hospital survival rate
timeFrame: From ICU admission until date of death from any cause, during hospitalization
measure: 90 days survival rate
timeFrame: From ICU admission until date of death from any cause, assessed up to 90 days after neuromuscular blokade removal
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: Milan
city: Genova
country: Italy
facility: Ospedale San Martino
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Trento
country: Italy
facility: APSS Provincia Autonoma di Trento Ospedale Santa Chiara
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Emilia Privitera, MSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.