Respiratory Physiotherapy in Severe COVID-19 Patients

COVID-19 Clinical Trial

— FTR-COVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04459819
• Other study ID #: FTR-COVID
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2020
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
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	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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 20 — View 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: 10.1 — View 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 infectio — View 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 failu — View 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, critic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of physiotherapy treatments	Total number of physiotherapy treatments performed on patients during hospitalization	Through study completion, an average of 60 days
Primary	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
Primary	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	First time standing	Median number of days from patients intubation to standing	From patient intubation to first time standing; up to 60 days
Secondary	First time walking	Median number of days from patients intubation to walking	From patient intubation to first time walking; up to 60 days
Secondary	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
Secondary	6 minutes walking test (6MWT)	Median distance (metres) obtained at the 6MWT	Assessed when patients are discharged from the hospital; up to 60 days
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	ICU stay length	Mean number of days patients stayed in ICU	From ICU admission to ICU discharge; up to 60 days.
Secondary	Length of hospitalization	Mean number of days patients stayed at the hospital	From hospital admission to hospital discharge; up to 60 days.
Secondary	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.
Secondary	Patients returned home	Number of patients that following hospital discharge returned home	Up to 60 days.
Secondary	Patients discharged to in-patient rehabilitation	Number of patients that were discharged from acute hospital to in-patient rehabilitation	Up to 60 days.
Secondary	Patients transferred to other hospitals	Number of patients that following hospital discharge were transferred to other hospitals	Up to 60 days.
Secondary	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.