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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04884061
Other study ID # PI2021_843_0096
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 7, 2021
Est. completion date July 2023

Study information

Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Vascular modifications have been described during SARS-CoV2 infection, especially a dilatation of the bronchial arteries. Within the airway wall, small branches of the bronchial arteries cross the muscle layer to develop a submucosal network. The Narrow Band Imaging technique is used during bronchoscopy to achieve a maximum contrast of vessels and the surrounding mucosa. Therefore, it enables to observe the microvessel structure and its distribution in the bronchial mucosa. The aim of this study is to describe the vasculature pattern of the bronchial tree during infection with SARS-CoV2.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 27
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients who undergo bronchoscopy with image and/or videos recording of NBI aspect of the proximal bronchial tree (carina, right and left upper lobe). - Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test - patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2) - Patients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2). Exclusion Criteria: - Patients under legal protection - Patients who refuses the use of his personal medical data

Study Design


Related Conditions & MeSH terms


Intervention

Other:
NBI images and/or videos
A library of NBI images and/or videos will be established from previously recorded bronchoscopies in 30 patients (10 with a SARS-CoV2 infection, 10 with a lower respiratory tract infection not related to SARS-CoV2, and 10 in patients with pulmonary nodule). NBI images and/or videos of the bronchial tree will then be analysed by three experimented interventional pulmonologists blinded to the patient ID. Each investigator will describe the vasculature pattern according to a prespecified grid: Normal mucosal vascularity / increased capillary density / presence of capillary loops / presence of dotted vessels / complex vascular networks of tortuous vessels or abrupt ending vessels / dilated longitudinal vessels. In case of discordance between the investigators, images will be reviewed to obtain a consensus.

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variation of the vasculature pattern of the bronchial mucosa between the three patient groups 2 months
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