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

Sponsor
Centre Hospitalier Intercommunal Creteil (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04191590
Collaborator
Foundation for Medical Research (Other)
94
2
2
61
47
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: nasal brushing and bacteriological sample
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2026
Anticipated Study Completion Date :
Nov 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Other: Patient with Chronic Rhinosinusitis (CRS)

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

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

Other: 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.

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Mucosal inflammation score (0 to 10) [Inclusion Visit]

    Mucosal inflammation score and presence of polyps during endoscopy

  2. Presence of pus at endoscopy [Inclusion Visit]

    Presence of pus at endoscopy

  3. Frequency of ciliary beat [Day of the surgical procedure under General Anesthesia]

    Frequency of the ciliary beat

  4. Shear stress by Tracking microbeads (mPa) [Day of the surgical procedure under General Anesthesia]

    Value of shear stress by tracking microbeads in mPa

  5. Presence of polyps at endoscopy [Inclusion Visit]

    Presence of polyps at endoscopy

  6. coordination of cillary beat [Day of the surgical procedure under General Anesthesia]

    Cillary beat coordination evaluated by microscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Acceptance to participate in the protocol with signed informed consent

  2. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Intercommunal de Créteil Créteil France 94000
2 Hôpital Bicêtre Le Kremlin-Bicêtre France

Sponsors and Collaborators

  • Centre Hospitalier Intercommunal Creteil
  • Foundation for Medical Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier:
NCT04191590
Other Study ID Numbers:
  • R-IMPAC
First Posted:
Dec 10, 2019
Last Update Posted:
Aug 18, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022