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Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot Study (EFRUPIC)

Primary Purpose

COVID-19

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
diaphragm ultrasonography
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for COVID-19 focused on measuring Lung function, Diaphragm ultrasonography, Chronic Inflammatory Rheumatism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • SARS-CoV-2 infection proven by RT-PCR.
  • Patient hospitalised for the management of SARS-CoV-2 infection and included 3 months after the end of his hospitalisation at the CHU of Limoges.
  • Patient of legal age.
  • Patient affiliated to a social security regime.
  • Patient having given informed consent

Exclusion Criteria:

  • Known pregnancy.
  • Patients who are contraindicated to perform the 6-minute walk test.
  • Patients unable to understand or adhere to the protocol.
  • Patients deprived of liberty.
  • Patients under court order, tutorship or curatorship.
  • Minor patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Cohort

    Arm Description

    All patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France)

    Outcomes

    Primary Outcome Measures

    The change diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia.
    Diaphragmatic amplitude assessed by ultrasound at M0 and M3.

    Secondary Outcome Measures

    the correlation between the values of diaphragmatic travel and Pi max and Pe max at M0 and M3.
    Diaphragmatic amplitude, PI max and PE max
    the difference in diaphragmatic amplitude between M0 and M3.
    Diaphragmatic amplitude at M0 and M3
    the difference in FEV1 between M0 and M3.
    FEV1 at M0 and M3.
    the difference in FVC between M0 and M3.
    FVC at M0 and M3.
    the difference in DLCO between M0 and M3.
    DLCO at M0 and M3.
    the difference in Pi max and Pe max between M0 and M3.
    PI max and PE max at M0 and M3
    dyspnoea between M0 and M3.
    mMRC dyspnoea scale at M0 and M3.
    the functional capacity between M0 and M3.
    6-minutes walk test distance at M0 and M3.

    Full Information

    First Posted
    September 30, 2021
    Last Updated
    October 8, 2021
    Sponsor
    University Hospital, Limoges
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05074927
    Brief Title
    Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot Study
    Acronym
    EFRUPIC
    Official Title
    Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 15, 2021 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Limoges

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The current state of knowledge shows the presence of respiratory sequelae after acute infection with COVID-19 and the importance of these long-term respiratory dysfunctions have to be determined. Aim of our study is describe diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia at 3 and 6 months after the acute episode.
    Detailed Description
    patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France) will be included to follow the impact of severe acute respiratory syndrom coronavirus 2 on pulmonary function, diaphragm function and exercice capacity. Surviving patients will be evaluated at 3 and 6 months after hospital discharge. The assesment will include diaphragm ultrasonography, spirometry (FEV1,FVC), carbon monoxide transfert (TLCO adjusted for haemoglobin), inspiratory an expiratory respiratory muscle strength (Pimax and Pemax) and 6 minutes walk distance (6MWD).The main outcome will be diaphragm excursion assessed by ultrasound.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19
    Keywords
    Lung function, Diaphragm ultrasonography, Chronic Inflammatory Rheumatism

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort
    Arm Type
    Other
    Arm Description
    All patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France)
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    diaphragm ultrasonography
    Intervention Description
    For all patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France) : diaphragm ultrasonography at 3 (M0) and 6 months (M3) after the end of his hospitalisation
    Primary Outcome Measure Information:
    Title
    The change diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia.
    Description
    Diaphragmatic amplitude assessed by ultrasound at M0 and M3.
    Time Frame
    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
    Secondary Outcome Measure Information:
    Title
    the correlation between the values of diaphragmatic travel and Pi max and Pe max at M0 and M3.
    Description
    Diaphragmatic amplitude, PI max and PE max
    Time Frame
    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
    Title
    the difference in diaphragmatic amplitude between M0 and M3.
    Description
    Diaphragmatic amplitude at M0 and M3
    Time Frame
    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
    Title
    the difference in FEV1 between M0 and M3.
    Description
    FEV1 at M0 and M3.
    Time Frame
    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
    Title
    the difference in FVC between M0 and M3.
    Description
    FVC at M0 and M3.
    Time Frame
    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
    Title
    the difference in DLCO between M0 and M3.
    Description
    DLCO at M0 and M3.
    Time Frame
    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
    Title
    the difference in Pi max and Pe max between M0 and M3.
    Description
    PI max and PE max at M0 and M3
    Time Frame
    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
    Title
    dyspnoea between M0 and M3.
    Description
    mMRC dyspnoea scale at M0 and M3.
    Time Frame
    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
    Title
    the functional capacity between M0 and M3.
    Description
    6-minutes walk test distance at M0 and M3.
    Time Frame
    at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: SARS-CoV-2 infection proven by RT-PCR. Patient hospitalised for the management of SARS-CoV-2 infection and included 3 months after the end of his hospitalisation at the CHU of Limoges. Patient of legal age. Patient affiliated to a social security regime. Patient having given informed consent Exclusion Criteria: Known pregnancy. Patients who are contraindicated to perform the 6-minute walk test. Patients unable to understand or adhere to the protocol. Patients deprived of liberty. Patients under court order, tutorship or curatorship. Minor patients
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    VINCENT François, Pr
    Phone
    05 55 05 61 45
    Email
    francois.vincent@chu-limoges.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    VINCENT François, Pr
    Organizational Affiliation
    CHU Limoges
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot Study

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