Clinical trial NCT05074927: Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot Study
Official title: Pulmonary Function in Patients Recovering From COVID19 Infection : a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: Lung function
Diaphragm ultrasonography
Chronic Inflammatory Rheumatism
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: The change diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia.
timeFrame: at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
Secondary outcomes:
measure: the correlation between the values of diaphragmatic travel and Pi max and Pe max at M0 and M3.
timeFrame: at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
measure: the difference in diaphragmatic amplitude between M0 and M3.
timeFrame: at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
measure: the difference in FEV1 between M0 and M3.
timeFrame: at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
measure: the difference in FVC between M0 and M3.
timeFrame: at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
measure: the difference in DLCO between M0 and M3.
timeFrame: at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
measure: the difference in Pi max and Pe max between M0 and M3.
timeFrame: at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
measure: dyspnoea between M0 and M3.
timeFrame: at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
measure: the functional capacity between M0 and M3.
timeFrame: at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges
Other outcomes:
Locations:
Study officials:
affiliation: CHU Limoges
name: VINCENT François, Pr
role: PRINCIPAL_INVESTIGATOR
References: