Respiratory Physiotherapy in Severe COVID-19 Patients (FTR-COVID)

Monocentric, Observational, Retrospective Study on Respiratory Physiotherapy in Severe COVID-19 Patients: the FTR-COVID 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.

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Respiratory physiotherapy

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.

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20122
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of physiotherapy treatments	Total number of physiotherapy treatments performed on patients during hospitalization	Through study completion, an average of 60 days
Type of physiotherapy treatments	Number of each activity performed on patients among early mobilization, positioning, Uso of non invasive ventilation (NIV) and/or continuous positive airway pressure (CPAP), oxygen titration, airway clearance.	Through study completion, an average of 60 days
Time of the first physiotherapy treatment	Median number of days from patients intubation to the first physiotherapy treatment	From patient intubation to first time patient was treated by a physiotherapist; up to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First time standing	Median number of days from patients intubation to standing	From patient intubation to first time standing; up to 60 days
First time walking	Median number of days from patients intubation to walking	From patient intubation to first time walking; up to 60 days
First time sitting out of bed	Median number of days from patients intubation to sitting out of bed	From patient intubation to first time sitting out of bed; up to 60 days
6 minutes walking test (6MWT)	Median distance (metres) obtained at the 6MWT	Assessed when patients are discharged from the hospital; up to 60 days
1 minute sit-to-stand test (1m-STST)	Median number of sit-to-stand repetitions obtained	Assessed when patients are discharged from the hospital; up to 60 days
Upper extremity muscles strength	Median upper extremity muscle strength measured by the Medical Research Council sum score (MRC-SS). The muscle scale grades muscle power on a scale of 0 (no visible muscle contraction) to 5 (active movement against full resistance). The movement tested are wrist flexion, forearm flexion and shoulder abduction.	Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days.
Lower extremity muscles strength	Median lower extremity muscle strength measured by the Medical Research Council sum score (MRC-SS). The muscle scale grades muscle power on a scale of 0 (no visible muscle contraction) to 5 (active movement against full resistance). The movement tested are ankle dorsiflexion, knee extension and hip flexion.	Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days.
Functional independence in ADL	Median score obtained th the Barthel Index for Activities of Daily Living (ADL). The Barthel Index measures functional independence in ADL. Scores range from 0 to 100, with higher scores indicating greater independence in ADL.	Assessed when the patient is discharged from the hospital; up to 60 days.
ICU stay length	Mean number of days patients stayed in ICU	From ICU admission to ICU discharge; up to 60 days.
Length of hospitalization	Mean number of days patients stayed at the hospital	From hospital admission to hospital discharge; up to 60 days.
Duration of invasive mechanical ventilation (IMV)	Mean number of days patients were invasively mechanically ventilated	From first day patient are mechanically ventilated to IMV stop; up to 60 days.
Patients returned home	Number of patients that following hospital discharge returned home	Up to 60 days.
Patients discharged to in-patient rehabilitation	Number of patients that were discharged from acute hospital to in-patient rehabilitation	Up to 60 days.
Patients transferred to other hospitals	Number of patients that following hospital discharge were transferred to other hospitals	Up to 60 days.
Exitus	Number of patients that died from any cause during hospitalization	From ICU admission until date of death from any cause, assessed up to 60 days.

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): September 30, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: June 27, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: ICU; Early Rehabilitation; Respiratory Physiotherapy
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: FTR-COVID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No