NCT04853940

Brief Summary

Further knowledge regarding sequelae in severe COVID-19 patients who have required ICU admission for invasive mechanical ventilation is still needed. Available evidence suggests ongoing respiratory impairment and impact in quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

April 12, 2021

Last Update Submit

March 24, 2022

Conditions

Covid19

Keywords

COVID19Diaphragm ultrasoundRespiratory muscle strengthDyspneaExercise CapacityQuality of lifePost-ICU outcomes

Outcome Measures

Primary Outcomes (2)

  • Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)

    It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.

    < 3 months after ICU discharge

  • Maximal Inspiratory Pressure (MIP) (centimetres of water, cmH20)

    It is the greater pressure which may be generated during maximal inspiration by the inspiratory muscles.

    within 6 months after ICU discharge

Secondary Outcomes (14)

  • Diaphragm Thickening Ratio during deep breathing (centimetres)

    within 3 months after ICU discharge

  • Diaphragm Thickening Ratio during deep breathing (centimetres)

    within 6 months after ICU discharge

  • Diaphragm Thickening Ratio during quiet breathing (centimetres)

    within 3 months after ICU discharge

  • Diaphragm Thickening Ratio during quiet breathing (centimetres)

    within 6 months after ICU discharge

  • Diaphragm Excursion during deep breathing (centimetres)

    within 3 months after ICU discharge

  • +9 more secondary outcomes

Interventions

Data collection and clinical testing of subjectsOTHER

6-months follow-up with clinical testing at 3 and 6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with COVID19 pneumonia who are discharged from the Ramón y Cajal University Hospital ICU from 1 October 2020 to 28 February 2021 will be eligible for the study

You may qualify if:

  • ⋧18 years old,
  • subjects diagnosed with COVID-19 confirmed by positive SARS-CoV-2 PCR testing who require admission to ICU for invasive mechanical ventilation
  • invasive ventilation \> 24 hours.

You may not qualify if:

  • pre-existing cognitive impairment,
  • communication/language barrier
  • any concurrent physical or mental health condition/ impairment that prevents subjects from taking part in evaluations or providing informed consent
  • loss of independent walking ability (with or without walking aids) prior to hospitalisation defined by a score of ≤2 on the mobility item of the modified Barthel Index,
  • pregnancy,
  • any injuries/surgery that requires medical bed rest.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU. Ramón y Cajal University Hospital

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

COVID-19Dyspnea

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Luís López-González, BSc,MSc

    Fundación Ramón y Cajal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist, MSc

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 22, 2021

Study Start

January 1, 2021

Primary Completion

November 30, 2021

Study Completion

January 1, 2022

Last Updated

April 5, 2022

Record last verified: 2022-03

Locations

ES(1)