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

Completed

• Conditions: COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Procedure: Early physiotherapy

• Registration Number: NCT05067907
• Lead Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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.

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-03-01
• Status Verified: 2021-06
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-05
• Primary Completion: 2021-10-30
• Study Completion: 2021-12-30
• Last Update Submitted: 2022-07-16
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Physiotherapy	Early physiotherapy	COVID-19 ICU-admitted patients that received physiotherapy interventions during ICU stay.

Primary Outcome Measures

Name	Time	Method
Ventilator-free days (VFD) and alive at day 28	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 Outcome Measures

Name	Time	Method
PaO2/FiO2	At ICU discharge; up to 60 days	Mean measure of PaO2/FiO2
ICU survival rate	From ICU admission until date of death from any cause, during ICU stay; up to 100 days.	Number of patients that survived ICU stay
hospital survival rate	From ICU admission until date of death from any cause, during hospitalization	Number of patients that survived hospitalization
ICU stay duration	From ICU admission to ICU discharge; up to 60 days.	Mean days of ICU stay
90 days survival rate	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

Trial Locations

Locations (4)

APSS Provincia Autonoma di Trento Ospedale Santa Chiara; 🇮🇹 Trento, Italy

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Milan, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; 🇮🇹 Milano, Italy

Ospedale San Martino; 🇮🇹 Genova, Italy