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

Centre Hospitalier Intercommunal Creteil

Status: Not yet enrolling

Conditions: Chronic Rhinosinusitis (Diagnosis)

Treatments: Procedure: nasal brushing and bacteriological sample

Study type: Interventional

Funder types: Other

Identifiers

NCT04191590

R-IMPAC

Details and patient eligibility

About

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

Full description

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.

Enrollment: 94 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Patient with Chronic Rhinosinusitis (CRS)

Other group

Description:

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

Treatment:

Procedure: nasal brushing and bacteriological sample

Patient without Chronic Rhinosinusitis (CRS)

Other group

Description:

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.

Treatment:

Procedure: nasal brushing and bacteriological sample