Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks: (R-IMPAC)

NCT ID: NCT04191590

Last Updated: 2023-09-06

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2028-07-01

Brief Summary

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Impact of chronic rhinosinusitis on the index of ciliary beat efficiency using fluorescent nanosticks

Detailed Description

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To date, the assessment of ciliary beat is only possible ex vivo on epithelial cells obtained from upper airway brushing. A previous prospective study (I-IsBac) showed a change in ciliary beat (in terms of coordination and frequency) in bacterial rhinosinusitis. The study of ex-vivo ciliary movement appears to be an interesting tool to understand the pathophysiology of CSRs and to guide and evaluate treatment.

A new tool to evaluate the effectiveness of the ex-vivo lash beat has been developed. This tool measures shear stress by tracking balls along the ciliary margin.

This measurement of ex-vivo shear stress by bead tracking is a validated technique. However, microbead tracking is limited by its low spatial and temporal resolution, long measurement time and heavy post-processing of acquisition data, making this method difficult to use in clinical routine. Monitoring ex-vivo fluorescent nano-batons could represent a simpler alternative for the clinician. This measurement is now made possible by Phosphate Lanthanum Lanthanum Nano-batons (LaPO4) whose luminescence is directly proportional to the shear.

The objective of this research project is to validate this new tool in patients with CSR by comparing it to a group of control subjects free of nasal inflammation.

Conditions

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Chronic Rhinosinusitis (Diagnosis)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient with Chronic Rhinosinusitis (CRS)

Patients with endonasal surgery scheduled under general anesthesia for an indication of Chronic Rhinosinusitis (CRS)

Group Type OTHER

nasal brushing and bacteriological sample

Intervention Type PROCEDURE

A nasal brushing as well as a bacteriological sample using a swab under general anesthesia at the beginning of the endonasal surgery procedure

Patient without Chronic Rhinosinusitis (CRS)

Patients with endonasal surgery scheduled under general anesthesia for an indication of endonasal surgery for nasal obstruction or patients requiring an endonasal surgical approach such as pituitary adenomas for example.

Group Type OTHER

nasal brushing and bacteriological sample

Intervention Type PROCEDURE

A nasal brushing as well as a bacteriological sample using a swab under general anesthesia at the beginning of the endonasal surgery procedure

Interventions

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nasal brushing and bacteriological sample

A nasal brushing as well as a bacteriological sample using a swab under general anesthesia at the beginning of the endonasal surgery procedure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patient ≥ 18 years old

* Having chronic rhinosinusitis (RCS) requiring surgical treatment. Or
* With an indication for endonasal surgery for nasal obstruction (turbinoplasty and septoplasty) or for an endonasal surgical approach
2. Acceptance to participate in the protocol with signed informed consent
3. Affiliated or beneficiary of a social security scheme

Exclusion Criteria

1. Refusal to participate in the study
2. No one who does not speak or understand French
3. Pregnant or breastfeeding woman
4. Persons who are incapable of reaching the age of majority, under guardianship, guardianship or protection of justice.
5. Simulated participation in another intervention research
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Medical Research

OTHER

Sponsor Role collaborator

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Site Status

Hôpital Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

Countries

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France

Central Contacts

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Camille JUNG, MD

Role: CONTACT

01 57 02 22 68 ext. +33

Facility Contacts

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Emilie BEQUIGNON, MD

Role: primary

01 45 17 50 00 ext. +33(1)

Jean-Françoois PAPON, PhD

Role: primary

Other Identifiers

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R-IMPAC

Identifier Type: -

Identifier Source: org_study_id

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