COVID-19 Acute Respiratory Distress SyndromeNCT05067907
Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients.
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 4 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- Early physiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 244 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Mar 2021to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Previuos cognitive deficit (Mini menatal state examination <20)
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Ospedale San Martino
Genova
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milan
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
APSS Provincia Autonoma di Trento Ospedale Santa Chiara
Trento
About this study
Official title: Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients: a Multicentric, National, Observational, Retrospective Study.
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.
Read the 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.
- Being tested
- Early physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early physiotherapyProcedure or surgery
Also called respiratory physiotherapy, early rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Early physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days after neuromuscular blokade stop
Secondary outcomes (5)
ICU stay duration
Mean days of ICU stay
Measured: From ICU admission to ICU discharge; up to 60 days.
PaO2/FiO2
Mean measure of PaO2/FiO2
Measured: At ICU discharge; up to 60 days
ICU survival rate
Number of patients that survived ICU stay
Measured: From ICU admission until date of death from any cause, during ICU stay; up to 100 days.
hospital survival rate
Number of patients that survived hospitalization
Measured: From ICU admission until date of death from any cause, during hospitalization
90 days survival rate
Number of patients that survived during 90 days after neuromuscular blokade stop
Measured: From ICU admission until date of death from any cause, assessed up to 90 days after neuromuscular blokade removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Mar 2021
- Primary completion30 Oct 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilia Privitera, MSC, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067907
- Sponsor's protocol ID
- FISIO-UTI-COVID
- Status last verified
- Jun 2021
- First submitted
- 30 Aug 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31986264Morris 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.
PubMed 18596631Schweickert 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.
PubMed 19446324Kim 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.
PubMed 32166241Lazzeri 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.
PubMed 32236089Privitera 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.
PubMed 36172535
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Respiratory Physiotherapy on Severe ICU-admitted COVID-19 Patients: a Multicentric, National, Observational, Retrospective Study.
- ClinicalTrials.gov ID
- NCT05067907
- Acronym / sponsor ID
- FISIO-UTI-COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –COVID-19 ICU-admitted patients that did not received physiotherapy interventions during ICU stay. |
| Physiotherapy | – | Procedure: Early physiotherapyCOVID-19 ICU-admitted patients that received physiotherapy interventions during ICU stay. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Previuos cognitive deficit (Mini menatal state examination <20)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early physiotherapyAlso: respiratory physiotherapy, early rehabilitationRespiratory 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. | Procedure or surgery | Physiotherapy |
Primary outcome
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.
5 secondary outcomes
ICU stay duration
Time frame: From ICU admission to ICU discharge; up to 60 days.
PaO2/FiO2
Time frame: At ICU discharge; up to 60 days
ICU survival rate
Time frame: From ICU admission until date of death from any cause, during ICU stay; up to 100 days.
hospital survival rate
Time frame: From ICU admission until date of death from any cause, during hospitalization
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Results publication: PubMed 31986264Huang 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.
- Results publication: PubMed 18596631Morris 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.
- Results publication: PubMed 19446324Schweickert 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.
- Results publication: PubMed 32166241Kim 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.
- Results publication: PubMed 32236089Lazzeri 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.
- Derived from this study: PubMed 36172535Privitera 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Privitera, MSC principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Acute Respiratory Distress Syndrome, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days (VFD) and alive at day 28 (time frame: Up to 28 days after neuromuscular blokade stop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05067907, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.