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

Sponsor

University Hospital, Limoges (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05074927

Collaborator

(none)

Enrollment

Arm

8.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Diagnostic Test: diaphragm ultrasonography	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Limoges

Investigators

Principal Investigator: VINCENT François, Pr, CHU Limoges

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Limoges

ClinicalTrials.gov Identifier:

NCT05074927

Other Study ID Numbers:

87RI20_0073

First Posted:

Oct 12, 2021

Last Update Posted:

Oct 12, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Limoges

Lung function

Diaphragm ultrasonography

Chronic Inflammatory Rheumatism

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Oct 12, 2021