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Clinical Trials/NCT04459819
NCT04459819
Completed
Not Applicable

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

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 site in 1 country84 target enrollmentMarch 1, 2020
ConditionsCOVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Enrollment
84
Locations
1
Primary Endpoint
Type of physiotherapy treatments
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
September 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

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)

Outcomes

Primary Outcomes

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.

Number of physiotherapy treatments

Time Frame: Through study completion, an average of 60 days

Total number of physiotherapy treatments performed on patients during hospitalization

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 Outcomes

  • First time standing(From patient intubation to first time standing; up to 60 days)
  • First time walking(From patient intubation to first time walking; up to 60 days)
  • First time sitting out of bed(From patient intubation to first time sitting out of bed; up to 60 days)
  • 6 minutes walking test (6MWT)(Assessed when patients are discharged from the hospital; up to 60 days)
  • 1 minute sit-to-stand test (1m-STST)(Assessed when patients are discharged from the hospital; up to 60 days)
  • Lower extremity muscles strength(Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days.)
  • Patients discharged to in-patient rehabilitation(Up to 60 days.)
  • Exitus(From ICU admission until date of death from any cause, assessed up to 60 days.)
  • Upper extremity muscles strength(Assessed at 2 time points, when patients are discharged from ICU and when patients are discharged from the hospital; up to 60 days.)
  • ICU stay length(From ICU admission to ICU discharge; up to 60 days.)
  • Functional independence in ADL(Assessed when the patient is discharged from the hospital; up to 60 days.)
  • Length of hospitalization(From hospital admission to hospital discharge; up to 60 days.)
  • Duration of invasive mechanical ventilation (IMV)(From first day patient are mechanically ventilated to IMV stop; up to 60 days.)
  • Patients returned home(Up to 60 days.)
  • Patients transferred to other hospitals(Up to 60 days.)

Study Sites (1)

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