Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Implementation of Physiotherapy on COVID-19 Patients in ICU (PHYSIO-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347070
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : April 16, 2020
Sponsor:
Collaborators:
Société espagnole de pneumologie (SEPAR)
Societe française de kinésithérapie en réanimation (SKR)
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Despite new charachersitics of COVID-19 patients, critical care implementation seems to be similar to those with Acute Respiratory Distress Syndrome (ARDS) in intensive care units (ICU).

Regarding the initial gravity of these patients, sedation and neuromuscular blockers are usually administrated, increasing the risk to develope an ICU-acquired weakness which is directly correlated to morbi-mortality and a burden during recovery.

Respiratory symptoms are mostly related to dyspnoea and non-productive cough, with only 33% of COVID-19 patient having a bronchial hypersecretion ; consequently, chest physiotherapy is only implemented in after case-by-case evaluation.

This unprecedented situation requires to identify how physiotherapy is being implemented in COVID-19 patients in ICU.

This retrospective, multicentric study aims to identify the charactheristics of physiotherapy (type and time spent) implemented in Argentina, Belgium, Chili, France, Italy and Spain


Condition or disease Intervention/treatment
Sars-CoV2 COVID-19 Other: Phsyiotherapy

Detailed Description:
  • Demographics data : hospitalisation date, ICU date, COVID+ date, extubation date, discharge date, mortality
  • ICU data : ventilatory mode, type of physiotherapy implemented (early rehabilitation, chest physiotherapy, time spent (minutes), number of interventions per day.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Implementation of Physiotherapy on COVID-19 Patients in Intensive Care Units : a Retrospective, Multicentric, International Study
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2022

Group/Cohort Intervention/treatment
Patients accepted in ICU diagnosed with COVID-19
Patients accepted in ICU diagnosed with COVID-19
Other: Phsyiotherapy
To observe if patients with COVID-19 benefice of physiothersapy, which kind and how many time




Primary Outcome Measures :
  1. Time of physiotherapy [ Time Frame: 1 day ]
    Time of physiotherapy (minutes)

  2. Time of physiotherapy [ Time Frame: 3 day ]
    Time of physiotherapy (minutes)

  3. Time of physiotherapy [ Time Frame: 7 day ]
    Time of physiotherapy (minutes)


Secondary Outcome Measures :
  1. Type of physiotherapy implemented [ Time Frame: 1 day ]
    Type of physiotherapy , early rehabilitation or chest phsyitoherapy

  2. Type of physiotherapy implemented [ Time Frame: 3 day ]
    Type of physiotherapy , early rehabilitation or chest phsyitoherapy

  3. Type of physiotherapy implemented [ Time Frame: 7 day ]
    Type of physiotherapy , early rehabilitation or chest phsyitoherapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted in ICU with COVID-19 will be eligible
Criteria

Inclusion criteria:

  • Age > 18 years
  • Patient admitted in ICU
  • Patient with COVID-19 diagnosis

Exclusion criteria:

- Explicite denie to participate in the study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347070


Contacts
Layout table for location contacts
Contact: roberto Martinez-Alejos, Physiotherapis 677952556 ext 33 r-martinezalejos@chu-montpellier.fr
Contact: Gustavo Plotnikow, Physiotherapis 49116543771 ext 33 gplotnikow@gmail.com

Locations
Layout table for location information
France
Uhmontpellier Recruiting
Montpellier, France, 34295
Contact: Roberto Martinez-Alejos       r-martinezalejos@chu-montpellier.fr   
Contact: Gustavo Plotnikow       gplotnikow@gmail.com   
Sponsors and Collaborators
University Hospital, Montpellier
Société espagnole de pneumologie (SEPAR)
Societe française de kinésithérapie en réanimation (SKR)
Investigators
Layout table for investigator information
Study Director: Roberto Martinez-Alejos, MD, PhD University Hospital, Montpellier
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04347070    
Other Study ID Numbers: RECHMPL20_0175
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
COVID-19
Physiotherapy
implementation
critical care