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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: diaphragm ultrasonography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort<br>All patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France) | Diagnostic Test: diaphragm ultrasonography<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia. | Diaphragmatic amplitude assessed by ultrasound at M0 and M3. | at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges | 
| the difference in diaphragmatic amplitude between M0 and M3. | Diaphragmatic amplitude at M0 and M3 | at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges | 
| the difference in FEV1 between M0 and M3. | FEV1 at M0 and M3. | at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges | 
| the difference in FVC between M0 and M3. | FVC at M0 and M3. | at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges | 
| the difference in DLCO between M0 and M3. | DLCO at M0 and M3. | at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges | 
| the difference in Pi max and Pe max between M0 and M3. | PI max and PE max at M0 and M3 | at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges | 
| dyspnoea between M0 and M3. | mMRC dyspnoea scale at M0 and M3. | at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges | 
| the functional capacity between M0 and M3. | 6-minutes walk test distance at M0 and M3. | at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung function, Diaphragm ultrasonography, Chronic Inflammatory Rheumatism