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

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ClinicalTrials.gov Identifier: NCT04459819

Recruitment Status : Recruiting

First Posted : July 7, 2020

Last Update Posted : August 11, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Description

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.

Condition or disease	Intervention/treatment
COVID-19	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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	80 participants
Observational Model:	Case-Only
Time Perspective:	Retrospective
Official Title:	Monocentric, Observational, Retrospective Study on Respiratory Physiotherapy in Severe COVID-19 Patients: the FTR-COVID Study.
Actual Study Start Date :	March 1, 2020
Estimated Primary Completion Date :	September 30, 2020
Estimated Study Completion Date :	September 30, 2020

Groups and Cohorts

Intervention Details:

Other: Respiratory physiotherapy
Respiratory physiotherapy consists of:
- early mobilization (passive and active mobilization, muscle-strengthening exercises, mobilization out of bed, standing, walking, ADL)
- patients positioning
- non-invasive mechanical ventilation / CPAP
- tracheostomy management
- invasive mechanical ventilation weaning
- airway clearance
- oxygen titration

Outcome Measures

Primary Outcome Measures :

Number of physiotherapy treatments [ Time Frame: Through study completion, an average of 60 days ]
Total number of physiotherapy treatments performed on patients during hospitalization
Type of physiotherapy treatments [ Time Frame: Through study completion, an average of 60 days ]
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.
Time of the first physiotherapy treatment [ Time Frame: From patient intubation to first time patient was treated by a physiotherapist; up to 60 days ]
Median number of days from patients intubation to the first physiotherapy treatment

Secondary Outcome Measures :

First time standing [ Time Frame: From patient intubation to first time standing; up to 60 days ]
Median number of days from patients intubation to standing
First time walking [ Time Frame: From patient intubation to first time walking; up to 60 days ]
Median number of days from patients intubation to walking
First time sitting out of bed [ Time Frame: From patient intubation to first time sitting out of bed; up to 60 days ]
Median number of days from patients intubation to sitting out of bed
6 minutes walking test (6MWT) [ Time Frame: Assessed when patients are discharged from the hospital; up to 60 days ]
Median distance (metres) obtained at the 6MWT
1 minute sit-to-stand test (1m-STST) [ Time Frame: Assessed when patients are discharged from the hospital; up to 60 days ]
Median number of sit-to-stand repetitions obtained
Upper extremity muscles strength [ Time Frame: Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days. ]
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.
Lower extremity muscles strength [ Time Frame: Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days. ]
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.
Functional independence in ADL [ Time Frame: Assessed when the patient is discharged from the hospital; up to 60 days. ]
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.
ICU stay length [ Time Frame: From ICU admission to ICU discharge; up to 60 days. ]
Mean number of days patients stayed in ICU
Length of hospitalization [ Time Frame: From hospital admission to hospital discharge; up to 60 days. ]
Mean number of days patients stayed at the hospital
Duration of invasive mechanical ventilation (IMV) [ Time Frame: From first day patient are mechanically ventilated to IMV stop; up to 60 days. ]
Mean number of days patients were invasively mechanically ventilated
Patients returned home [ Time Frame: Up to 60 days. ]
Number of patients that following hospital discharge returned home
Patients discharged to in-patient rehabilitation [ Time Frame: Up to 60 days. ]
Number of patients that were discharged from acute hospital to in-patient rehabilitation
Patients transferred to other hospitals [ Time Frame: Up to 60 days. ]
Number of patients that following hospital discharge were transferred to other hospitals
Exitus [ Time Frame: From ICU admission until date of death from any cause, assessed up to 60 days. ]
Number of patients that died from any cause during hospitalization

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
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.

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459819

Contacts

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Contact: Emilia Privitera, MSC	0039 3385670909	emilia.privitera@policlinico.mi.it
Contact: Martina Santambrogio, PhD	0039 3393838807	martina.santambrogio@policlinico.mi.it

Locations

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Italy
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	Recruiting
Milan, Italy, 20122
Contact: Emilia Privitera, MSC 0039 3385670909 emilia.privitera@policlinico.mi.it
Contact: Martina Santambrogio, PhD 0039 3393838807 martina.santambrogio@policlinico.mi.it

Sponsors and Collaborators

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

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Principal Investigator:	Emilia Privitera, MSC	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

More Information

Publications of Results:

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.

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Responsible Party:	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:	NCT04459819
Other Study ID Numbers:	FTR-COVID
First Posted:	July 7, 2020 Key Record Dates
Last Update Posted:	August 11, 2020
Last Verified:	August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:


ICU Respiratory Physiotherapy Early Rehabilitation

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