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NCT Number: NCT05067907

Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients.

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.

Early rehabilitation is known to be effective in critically ill subjects. The role of physiotherapy in severe COVID-19 patients is still unclear and few guidelines have been proposed so far. Aim of this study is to assess efficacy of early rehabilitation for severe ICU-admitted COVID-19 patients as compared to a group that did not received physiotherapy treatment in ICU.

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Key information

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy

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About this study

COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which emerged in China in December 2019 and in Italy in February 2020. A large proportion of infected people have mild clinical manifestations, whereas >10% develop a severe disease, which could evolve into acute hypoxemic respiratory failure (AHRF) and acute respiratory distress syndrome (ARDS) requiring intensive care unit (ICU) admission. A high proportion of ICU patients need invasive mechanical ventilation (IMV) and about 50% of the ICU-admitted patients die. The median age of ICU COVID-19 patients was <65 years and the mortality in patients aged <63 years ranges from 15 to 20%.

Early rehabilitation is safe and effective in critically ill patients and, in patients with ARDS, it helps to reduce the functional impairment due to the prolonged stay in ICU. Preliminary data suggest the implementation of early and active mobilization programs, as well as airway clearance, for patients with severe forms of COVID-19. To date, the role of respiratory physiotherapy in severe COVID-19 patients is still unclear.

Aim of this study is to assess efficacy of early rehabilitation for severe ICU-admitted COVID-19 patients as compared to a group that did not recevied physiotherapy treatment in ICU. Physiotherapy efficacy is evaluated in terms of ventilator free days (VFD) during the first 30 days after neuromuscular blockade stop.

Moreover, duration of ICU stay and patient functional status at ICU discharge will be evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having laboratory confirmed COVID-19 pneumonia
  • Developed hypoxemic acute respiratory failure (hARF) requiring access to ICU
  • Treated by physiotherapists during the ICU stay
  • Stopped the neuromuscular blokade treatment

Exclusion criteria

  • Previuos cognitive deficit (Mini menatal state examination <20)

Treatment and study plan

Early physiotherapy

Procedure

Respiratory physiotherapy included:

  • early and functional mobilization: passive and active mobilization, muscle strengthening, improving independence in activities of daily living (ADL), sitting out of bed, standing, walking;
  • patient positioning to achieve better ventilation/perfusion ratio and gas exchange;
  • airway clearance;
  • aerosol administration;
  • invasive mechanical ventilation weaning;
  • use of non-invasive mechanical ventilation (NIMV) and continuous positive airway pressure (CPAP);
  • tracheostomy management and weaning;
  • swallowing assessment;
  • management of oxygen delivery;
  • lung expansion;
  • patient assessment and functional scale administration.

Other names: respiratory physiotherapy, early rehabilitation

Primary outcomes

  1. Ventilator-free days (VFD) and alive at day 28

    Time frame: Up to 28 days after neuromuscular blokade stop

    To determine if early physiotherapy, as compared to no physiotherapy treatment, increases the number of ventilator-free days (VFD) and alive at day 28 in severe COVID-19 ICU-admitted patients.

Secondary outcomes

  1. ICU stay duration

    Time frame: From ICU admission to ICU discharge; up to 60 days.

    Mean days of ICU stay

  2. PaO2/FiO2

    Time frame: At ICU discharge; up to 60 days

    Mean measure of PaO2/FiO2

  3. ICU survival rate

    Time frame: From ICU admission until date of death from any cause, during ICU stay; up to 100 days.

    Number of patients that survived ICU stay

  4. hospital survival rate

    Time frame: From ICU admission until date of death from any cause, during hospitalization

    Number of patients that survived hospitalization

  5. 90 days survival rate

    Time frame: From ICU admission until date of death from any cause, assessed up to 90 days after neuromuscular blokade removal

    Number of patients that survived during 90 days after neuromuscular blokade stop

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients: a Multicentric, National, Observational, Retrospective Study.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2021
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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