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

Not Applicable

• Conditions: COVID-19
• Interventions: Diagnostic Test: diaphragm ultrasonography

• Registration Number: NCT05074927
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-08
• Last Update Submitted: 2021-10-08
• Study First Posted: 2021-10-12
• Last Update Posted: 2021-10-12
• Study Start: 2021-10-15
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort	diaphragm ultrasonography	All patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
the correlation between the values of diaphragmatic travel and 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	Diaphragmatic amplitude, PI max and PE max
the difference in diaphragmatic amplitude between M0 and M3.	at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges	Diaphragmatic amplitude at M0 and M3
the difference in FEV1 between M0 and M3.	at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges	FEV1 at M0 and M3.
the difference in FVC between M0 and M3.	at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges	FVC at M0 and M3.
the difference in DLCO between M0 and M3.	at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges	DLCO at M0 and M3.
the difference in Pi max and Pe max between M0 and M3.	at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges	PI max and PE max at M0 and M3
dyspnoea between M0 and M3.	at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges	mMRC dyspnoea scale at M0 and M3.
the functional capacity between M0 and M3.	at 3 (M0) and 6 months (M3) after the end of his hospitalisation at the CHU of Limoges	6-minutes walk test distance at M0 and M3.