Narrow Band Imaging Bronchoscopy During SARS-CoV2 Infection

NCT04884061 | Unknown

• 1 other identifier: PI2021_843_0096
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Bronchoscopy; Narrow-band Imaging

Keywords

Covid19; bronchoscopy; Narrow-band imaging; bronchial vasculature; Acute vascular distress syndrome

Outcome Measures

Primary Outcomes (1)

• Variation of the vasculature pattern of the bronchial mucosa between the three patient groups

  2 months

Study Arms (3)

Experimental

Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test

Other: NBI images and/or videos

Comparator

Patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2)

Other: NBI images and/or videos

Comparator 2

Patients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2).

Other: NBI images and/or videos

Interventions

NBI images and/or videos OTHER

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.

Comparator; Comparator 2; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- Patients who undergo bronchoscopy with image and/or videos recording of NBI aspect of the proximal bronchial tree (carina, right and left upper lobe). Three groups of patients will be selected: 1) Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test ; 2) patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2) ; 3) Patients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2).

You may qualify if:

• 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).

You may not qualify if:

• Patients under legal protection
• Patients who refuses the use of his personal medical data

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: May 7, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)