NCT06042881

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

August 7, 2023

Last Update Submit

September 14, 2023

Conditions

Keywords

physical therapycovidmechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Days of mechanical ventilation

    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 Outcomes (7)

  • days of stay

    2 months

  • Assess morbidity and mortality.

    2 months

  • Assess the comorbidities of patients admitted for COVID-19 in critical condition

    2 months

  • PNS lesion in prono position

    2 months

  • Assess the comorbidities of patients admitted for COVID-19 in critical condition

    2 months

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Dolça Gras Pacheco

CONTACT

Indalecio Morán Chorro

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2023

First Posted

September 21, 2023

Study Start

May 23, 2023

Primary Completion

July 31, 2023

Study Completion

October 30, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations