Clinical trial NCT04459819: Respiratory Physiotherapy in Severe COVID-19 Patients
Official title: Monocentric, Observational, Retrospective Study on Respiratory Physiotherapy in Severe COVID-19 Patients: the FTR-COVID Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: ICU
Respiratory Physiotherapy
Early Rehabilitation
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
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 1st, that were treated by respiratory physiotherapists during the whole hospitalization period.

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.

The role of respiratory physiotherapy in critical COVID-19 patients is still unclear.

The aim of this study is to describe the bundle and the timing of respiratory physiotherapy used with severe COVID-19 patients from ICU to hospital discharge. Functional condition of patients at discharge will be assessed and described.

Detailed description: COVID-19 is an infectious disease caused by SARS-CoV2 virus, that first appeared in China in 2019 and in Italy in February 2020.

Approximately 80% of people infected with COVID-19 have mild to moderate disease with few symptoms, while more than 10% 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) needing invasive mechanical ventilation (IMV) and hospitalization for a long period.

Early rehabilitation is known to be effective in critically ill patients and in ARDS, to reduce functional impairment due to the prolonged stay in ICU. Many works demonstrated that early rehabilitation programs in ICU correlated with faster recovery and discharge at home of ARDS patients and better outcomes in the walking test at discharge from the hospital.

Due to the recent development of COVID-19, few data and guidelines to menage severe COVID-19 patients are available and the role of respiratory physiotherapy is still unclear.

The aim of this study is to describe the bundle and the timing of respiratory physiotherapy used with severe COVID-19 patients from ICU to hospital discharge. Functional condition of patients at discharge will be assessed and described.

Eligibility criteria: Inclusion Criteria:

* Having laboratory confirmed COVID-19 pneumonia
* Developed hypoxemic acute respiratory failure (hARF) requiring access to ICU
* Treated by respiratory physiotherapists during the hospitalization period

Exclusion Criteria:

* Previously documented neurological or neuromuscular diseases
* Passed over 1 month in bed before COVID-19 diagnosis
* Documented cognitive impairment (mini mental state examination \<24)

Primary outcomes:
measure: Number of physiotherapy treatments
timeFrame: Through study completion, an average of 60 days
measure: Type of physiotherapy treatments
timeFrame: Through study completion, an average of 60 days
measure: Time of the first physiotherapy treatment
timeFrame: From patient intubation to first time patient was treated by a physiotherapist; up to 60 days
Secondary outcomes:
measure: First time standing
timeFrame: From patient intubation to first time standing; up to 60 days
measure: First time walking
timeFrame: From patient intubation to first time walking; up to 60 days
measure: First time sitting out of bed
timeFrame: From patient intubation to first time sitting out of bed; up to 60 days
measure: 6 minutes walking test (6MWT)
timeFrame: Assessed when patients are discharged from the hospital; up to 60 days
measure: 1 minute sit-to-stand test (1m-STST)
timeFrame: Assessed when patients are discharged from the hospital; up to 60 days
measure: Upper extremity muscles strength
timeFrame: Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days.
measure: Lower extremity muscles strength
timeFrame: Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days.
measure: Functional independence in ADL
timeFrame: Assessed when the patient is discharged from the hospital; up to 60 days.
measure: ICU stay length
timeFrame: From ICU admission to ICU discharge; up to 60 days.
measure: Length of hospitalization
timeFrame: From hospital admission to hospital discharge; up to 60 days.
measure: Duration of invasive mechanical ventilation (IMV)
timeFrame: From first day patient are mechanically ventilated to IMV stop; up to 60 days.
measure: Patients returned home
timeFrame: Up to 60 days.
measure: Patients discharged to in-patient rehabilitation
timeFrame: Up to 60 days.
measure: Patients transferred to other hospitals
timeFrame: Up to 60 days.
measure: Exitus
timeFrame: From ICU admission until date of death from any cause, assessed up to 60 days.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Department of Pathophysiology and Transplantation, University of Milan Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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.