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

• ClinicalTrials.gov Identifier: NCT04459819
• Recruitment Status: Recruiting
• First Posted: July 7, 2020
• Last Update Posted: August 11, 2020
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Information provided by (Responsible Party): Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Tracking Information

• First Submitted Date: June 27, 2020
• First Posted Date: July 7, 2020
• Last Update Posted Date: August 11, 2020
• Actual Study Start Date: March 1, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 3, 2020)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 3, 2020)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.

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.

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: COVID-19

Intervention

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

• Study Groups/Cohorts: Not Provided

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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 3, 2020): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2020
• Estimated Primary Completion Date: September 30, 2020 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Emilia Privitera, MSC; 0039 3385670909; emilia.privitera@policlinico.mi.it

Contact: Martina Santambrogio, PhD; 0039 3393838807; martina.santambrogio@policlinico.mi.it

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04459819
• Other Study ID Numbers: FTR-COVID
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Study Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Collaborators: Not Provided

Investigators

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

• PRS Account: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Verification Date: August 2020