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

NCT05067907 | Completed

• 1 other identifier: FISIO-UTI-COVID
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 4

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.

Conditions

COVID-19 Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 28 days after neuromuscular blokade stop

Secondary Outcomes (5)

• ICU stay duration

  From ICU admission to ICU discharge; up to 60 days.

• PaO2/FiO2

  At ICU discharge; up to 60 days

• ICU survival rate

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

• hospital survival rate

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

• 90 days survival rate

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

Study Arms (2)

Control

COVID-19 ICU-admitted patients that did not received physiotherapy interventions during ICU stay.

Physiotherapy

COVID-19 ICU-admitted patients that received physiotherapy interventions during ICU stay.

Procedure: Early physiotherapy

Interventions

Early physiotherapy PROCEDURE

Respiratory physiotherapy included: 1. early and functional mobilization: passive and active mobilization, muscle strengthening, improving independence in activities of daily living (ADL), sitting out of bed, standing, walking; 2. patient positioning to achieve better ventilation/perfusion ratio and gas exchange; 3. airway clearance; 4. aerosol administration; 5. invasive mechanical ventilation weaning; 6. use of non-invasive mechanical ventilation (NIMV) and continuous positive airway pressure (CPAP); 7. tracheostomy management and weaning; 8. swallowing assessment; 9. management of oxygen delivery; 10. lung expansion; 11. patient assessment and functional scale administration.

Also known as: respiratory physiotherapy, early rehabilitation

Physiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will study patients accessing acute hospital ICU with hypoxemic acute respiratory failure (hARF) due to laboratory confirmed COVID-19 pneumonia form March 1st to May 30th.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (4)

ASST Grande Ospedale Metropolitano Niguarda

Milan, Milan, Italy

Location

Ospedale San Martino

Genova, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

APSS Provincia Autonoma di Trento Ospedale Santa Chiara

Trento, Italy

Location

Related Publications (6)

• 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 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

  PMID: 31986264 RESULT

• 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 failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.

  PMID: 18596631 RESULT

• 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, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

  PMID: 19446324 RESULT

• 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: 10.1097/CCE.0000000000000060. eCollection 2019 Nov.

  PMID: 32166241 RESULT

• 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 infection in acute setting: a Position Paper of the Italian Association of Respiratory Physiotherapists (ARIR). Monaldi Arch Chest Dis. 2020 Mar 26;90(1). doi: 10.4081/monaldi.2020.1285.

  PMID: 32236089 RESULT

• Privitera E, Gambazza S, Rossi V, Santambrogio M, Binda F, Tarello D, Caiffa S, Turrin V, Casagrande C, Battaglini D, Panigada M, Fumagalli R, Pelosi P, Grasselli G. Association of ventilator-free days with respiratory physiotherapy in critically ill patients with Coronavirus Disease 2019 (COVID-19) during the first pandemic wave. A propensity score-weighted analysis. Front Med (Lausanne). 2022 Sep 12;9:994900. doi: 10.3389/fmed.2022.994900. eCollection 2022.

  PMID: 36172535 DERIVED

Study Officials

• Emilia Privitera, MSC

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: October 5, 2021
• Study Start: March 1, 2021
• Primary Completion: October 30, 2021
• Study Completion: December 30, 2021
• Last Updated: July 19, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)