Viewing Study NCT05067907



Ignite Creation Date: 2024-05-06 @ 4:42 PM
Last Modification Date: 2024-10-26 @ 2:14 PM
Study NCT ID: NCT05067907
Status: COMPLETED
Last Update Posted: 2022-07-19
First Post: 2021-08-30

Brief Title: Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients
Sponsor: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Study Overview

Official Title: Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients a Multicentric National Observational Retrospective Study
Status: COMPLETED
Status Verified Date: 2021-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None