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)
50
Enrollment
1
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

  1. 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

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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:
No
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:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Limoges
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 12, 2021