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

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

— R-IMPAC  

Official title:

Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04191590
• Other study ID #: R-IMPAC
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: July 1, 2028

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Camille JUNG, MD
• Phone: 01 57 02 22 68
• Email: camille.jung[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: July 1, 2028
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Créteil	Créteil
France	Hôpital Bicêtre	Le Kremlin-Bicêtre

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Foundation for Medical Research

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The shear stresss by tracking nano-batons (mPa)	The value of the shear stress by tracking nano-batons in mPa	Day of the surgical procedure under General Anesthesia
Secondary	Mucosal inflammation score (0 to 10)	Mucosal inflammation score and presence of polyps during endoscopy	Inclusion Visit
Secondary	Presence of pus at endoscopy	Presence of pus at endoscopy	Inclusion Visit
Secondary	Frequency of ciliary beat	Frequency of the ciliary beat	Day of the surgical procedure under General Anesthesia
Secondary	Shear stress by Tracking microbeads (mPa)	Value of shear stress by tracking microbeads in mPa	Day of the surgical procedure under General Anesthesia
Secondary	Presence of polyps at endoscopy	Presence of polyps at endoscopy	Inclusion Visit
Secondary	coordination of cillary beat	Cillary beat coordination evaluated by microscopy	Day of the surgical procedure under General Anesthesia