Clinical trial NCT04191590: Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks: (R-IMPAC)
Official title: Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Foundation for Medical Research
First posted: 2019-12-10
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The shear stresss by tracking nano-batons (mPa)
timeFrame: Day of the surgical procedure under General Anesthesia
Secondary outcomes:
measure: Mucosal inflammation score (0 to 10)
timeFrame: Inclusion Visit
measure: Presence of pus at endoscopy
timeFrame: Inclusion Visit
measure: Frequency of ciliary beat
timeFrame: Day of the surgical procedure under General Anesthesia
measure: Shear stress by Tracking microbeads (mPa)
timeFrame: Day of the surgical procedure under General Anesthesia
measure: Presence of polyps at endoscopy
timeFrame: Inclusion Visit
measure: coordination of cillary beat
timeFrame: Day of the surgical procedure under General Anesthesia
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
Study officials:
References: