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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19
• Intervention / Treatment: Diagnostic test: diaphragm ultrasonography

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: VINCENT François, Pr; Phone Number: 05 55 05 61 45; Email: francois.vincent@chu-limoges.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort; All patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France)	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: VINCENT François, Pr, CHU Limoges

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Lung function; Diaphragm ultrasonography; Chronic Inflammatory Rheumatism
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 87RI20_0073

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No