Retrospective Cohort Study of the Physiotherapy in Critically Ill Covid Patients

September 14, 2023 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Retrospective Cohort Study of the Physiotherapy Procedure in Critically Ill Patients Diagnosed With COVID-19 During the First Wave

Retrospective cohort study that will include patients from the ICU of the Hospital de la Santa Creu i Sant Pau in Barcelona during the period between March 11 and May 13, 2020. The cohorts are made up of two groups of patients admitted for severe COVID during the first wave, according to whether or not they received physiotherapy and the possible impact of physiotherapy on the days of mechanical ventilation in the two study groups will be studied.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

189

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The sample size obtained will not be from any formal calculation, it will be a sample per convenience of inclusion of all patients admitted to the ICU with a diagnosis of COVID-19 During the study period, 189 subjects, with whom it is expected to achieve the objectives of the study.

Description

Inclusion Criteria:

  • Patients diagnosed with COVID-19 in critical condition
  • Adults >18 years
  • Admission to the ICU from March 11 to May 13, 2020

Exclusion Criteria:

  • Patients readmitted on 2 occasions during the study period, the second will be omitted income.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of mechanical ventilation
Time Frame: 2 months
To evaluate the effectiveness of early physiotherapy in critically ill patients with COVID-19 admitted to the ICU in terms of reducing days of mechanical ventilation
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
days of stay
Time Frame: 2 months
Evaluate the days of stay in the ICU
2 months
Assess morbidity and mortality.
Time Frame: 2 months
Assess morbidity and mortality.
2 months
Assess the comorbidities of patients admitted for COVID-19 in critical condition
Time Frame: 2 months
Assess the comorbidities of patients admitted for COVID-19 in critical condition
2 months
PNS lesion in prono position
Time Frame: 2 months
To know if there is a greater risk of suffering a PNS lesion the more rounds of pronation
2 months
Assess the comorbidities of patients admitted for COVID-19 in critical condition
Time Frame: 2 months
To know if the delay in the prescription of physiotherapy (FST) influences the appearance of PNS lesions.
2 months
Start of standing in critrically ill
Time Frame: 2 months
To evaluate the start of standing (BP) in critically ill patients infected with COVID-19 who underwent FST.
2 months
Workload in physiotherapy
Time Frame: 2 months
To assess the workload of the cohort of patients who underwent physiotherapy during the first wave of COVID-19.
2 months

Collaborators and Investigators

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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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)

May 23, 2023

Primary Completion (Actual)

July 31, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-COV-2022-36

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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