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

December 28, 2020 updated by: University Hospital, Montpellier

Implementation of Physiotherapy on COVID-19 Patients in Intensive Care Units : a Retrospective, Multicentric, International Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • UHMontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted in ICU with COVID-19 will be eligible

Description

Inclusion criteria:

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

Exclusion criteria:

- Explicite denie to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of physiotherapy
Time Frame: 1 day
Time of physiotherapy (minutes)
1 day
Time of physiotherapy
Time Frame: 3 day
Time of physiotherapy (minutes)
3 day
Time of physiotherapy
Time Frame: 7 day
Time of physiotherapy (minutes)
7 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of physiotherapy implemented
Time Frame: 1 day
Type of physiotherapy , early rehabilitation or chest phsyitoherapy
1 day
Type of physiotherapy implemented
Time Frame: 3 day
Type of physiotherapy , early rehabilitation or chest phsyitoherapy
3 day
Type of physiotherapy implemented
Time Frame: 7 day
Type of physiotherapy , early rehabilitation or chest phsyitoherapy
7 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Société espagnole de pneumologie (SEPAR)
Societe française de kinésithérapie en réanimation (SKR)

Investigators

  • Study Director: Roberto Martinez-Alejos, MD, PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2017

Primary Completion (ACTUAL)

September 1, 2020

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (ACTUAL)

April 15, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL20_0175

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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