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

COVID-19 Clinical Trial

— EFRUPIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05074927
• Other study ID #: 87RI20_0073
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: July 2022

Study information

• Verified date: September 2021
• Source: University Hospital, Limoges
• Contact: VINCENT François, Pr
• Phone: 05 55 05 61 45
• Email: francois.vincent[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• diaphragm ultrasonography
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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