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
About this trial
This is an interventional screening trial for COVID-19 focused on measuring Lung function, Diaphragm ultrasonography, Chronic Inflammatory Rheumatism
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
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
NCT ID
NCT05074927
First Posted
September 30, 2021
Last Updated
October 8, 2021
Sponsor
University Hospital, Limoges
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
Learn more about this trial
Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot Study
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