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

Not Applicable

Not yet recruiting

• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Interventions: Procedure: nasal brushing and bacteriological sample

• Registration Number: NCT04191590
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Study Timeline

• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-05
• Study First Posted: 2019-12-10
• Status Verified: 2023-08
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-06
• Study Start: 2023-12-01
• Primary Completion: 2027-05-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with Chronic Rhinosinusitis (CRS)	nasal brushing and bacteriological sample	Patients with endonasal surgery scheduled under general anesthesia for an indication of Chronic Rhinosinusitis (CRS)
Patient without Chronic Rhinosinusitis (CRS)	nasal brushing and bacteriological sample	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.

Primary Outcome Measures

Name	Time	Method
The shear stresss by tracking nano-batons (mPa)	Day of the surgical procedure under General Anesthesia	The value of the shear stress by tracking nano-batons in mPa

Secondary Outcome Measures

Name	Time	Method
Mucosal inflammation score (0 to 10)	Inclusion Visit	Mucosal inflammation score and presence of polyps during endoscopy
Presence of pus at endoscopy	Inclusion Visit	Presence of pus at endoscopy
Frequency of ciliary beat	Day of the surgical procedure under General Anesthesia	Frequency of the ciliary beat
Shear stress by Tracking microbeads (mPa)	Day of the surgical procedure under General Anesthesia	Value of shear stress by tracking microbeads in mPa
Presence of polyps at endoscopy	Inclusion Visit	Presence of polyps at endoscopy
coordination of cillary beat	Day of the surgical procedure under General Anesthesia	Cillary beat coordination evaluated by microscopy

Trial Locations

Locations (2)

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Centre Hospitalier Intercommunal de Créteil; 🇫🇷 Créteil, France