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

NCT ID: NCT05074927

Last Updated: 2021-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Cohort

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

Group Type OTHER

diaphragm ultrasonography

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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VINCENT François, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Limoges

Central Contacts

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VINCENT François, Pr

Role: CONTACT

[email protected]
05 55 05 61 45

Other Identifiers

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87RI20_0073

Identifier Type: -

Identifier Source: org_study_id