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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2022

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Other: Cohort
    • All patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France)

Clinical Trial Outcome Measures

Primary Measures

  • The change diaphragmatic amplitude using diaphragm ultrasonography in patients recovering from SARS-CoV-2 pneumonia.
    • Time Frame: 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 Measures

  • the correlation between the values of diaphragmatic travel and Pi max and Pe max at M0 and M3.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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.
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Limoges
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • VINCENT Fran├žois, Pr, Principal Investigator, CHU Limoges
  • Overall Contact(s)
    • VINCENT Fran├žois, Pr, 05 55 05 61 45, francois.vincent@chu-limoges.fr

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