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NCT Number: NCT05074927

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dupuytren, Limoges, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diaphragm ultrasonography

Diagnostic Test

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: EFRUPIC

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Oct 12, 2021
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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