Narrow Band Imaging Bronchoscopy During SARS-CoV2 Infection (SARS-CoV2-NBI)

Description of the Vasculature Pattern of the Bronchial Tree During Infection With SARS-CoV2 by Narrow Band Imaging Bronchoscopy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19; Bronchoscopy; Narrow-band Imaging
• Intervention / Treatment: Other: NBI images and/or videos

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80480
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental; Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test	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.
Comparator; Patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2)	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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Variation of the vasculature pattern of the bronchial mucosa between the three patient groups	2 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2021
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (ACTUAL): May 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Covid19; bronchoscopy; Narrow-band imaging; bronchial vasculature; Acute vascular distress syndrome
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PI2021_843_0096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No