Respiratory Physiotherapy in Severe COVID-19 Patients

NCT04459819 | Completed

• 1 other identifier: FTR-COVID
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

ICU; Respiratory Physiotherapy; Early Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Number of physiotherapy treatments

  Total number of physiotherapy treatments performed on patients during hospitalization

  Through study completion, an average of 60 days

• Type of physiotherapy treatments

  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.

  Through study completion, an average of 60 days

• Time of the first physiotherapy treatment

  Median number of days from patients intubation to the first physiotherapy treatment

  From patient intubation to first time patient was treated by a physiotherapist; up to 60 days

Secondary Outcomes (15)

• 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

Interventions

Respiratory physiotherapy OTHER

Respiratory physiotherapy consists of: * early mobilization (passive and active mobilization, muscle-strengthening exercises, mobilization out of bed, standing, walking, ADL) * patients positioning * non-invasive mechanical ventilation / CPAP * tracheostomy management * invasive mechanical ventilation weaning * airway clearance * oxygen titration

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 1st, that were treated by respiratory physiotherapists during the whole hospitalization period.

You may qualify if:

• Having laboratory confirmed COVID-19 pneumonia
• Developed hypoxemic acute respiratory failure (hARF) requiring access to ICU
• Treated by respiratory physiotherapists during the hospitalization period

You may not qualify if:

• Previously documented neurological or neuromuscular diseases
• Passed over 1 month in bed before COVID-19 diagnosis
• Documented cognitive impairment (mini mental state examination \<24)

Sponsors & Collaborators

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

Study Sites (1)

Department of Pathophysiology and Transplantation, University of Milan Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (5)

• 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

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Emilia Privitera, MSC

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: July 7, 2020
• Study Start: March 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 16, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)