NCT06909903

Cell Content of Sputum Induced by Hypertonic Saline in Adolescents With Cystic Fibrosis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Cystic fibrosis requires regular monitoring of bacterial colonization of sputum. The collection is done during scheduled consultations or urgently during exacerbations during the respiratory physiotherapy session, which is increasingly often associated with nebulization of Hypertonic Salt Serum (SSH). This allows, compared to simple expectoration, to obtain a greater density and diversity of germs. However, no study has focused on researching the precise place of origin of the collected secretions. Our aim is therefore to compare, in this pilot study in 20 adolescents suffering from cystic fibrosis and regularly followed at the pediatric CRCM, the ratio between squamous cells (CM, ENT origin) and broncho-alveolar cells in sputum obtained spontaneously and induced with of the SSH (collaboration with Professor Roll). The secondary criteria are the CM/bronchial cell ratio, the CM/alveolar macrophage ratio, cell viability and microbiological diversity. The hypothesis of this research is as follows: the nebulization of SSH before expectoration makes it possible to obtain a greater quantity of secretions from the broncho-alveolar sphere than during simple expectoration. In the cohort of 165 patients followed at the pediatric CRCM of Marseille, only 25 patients correspond to the inclusion criteria: they are between 12 and 17 years old, master autogenous drainage as well as spontaneous expectoration in sufficient quantity to carry out the research. They must also have been in stable clinical condition for at least one month. Taking into account the non-inclusion criteria (refusal to participate, systemic antibiotic therapy, respiratory decompensation or upper airway infection, SpO2 less than 92% before nebulization, appearance of hemoptysis in the last three months), the number of subjects is fixed. To 20. Each patient participates in a single day of hospitalization scheduled at the pediatric CRCM: at 9 a.m. simple expectoration and at 1 p.m., expectoration caused by SSH. The subject is therefore his own witness. The study inclusion period is one year.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
PROCEDURE	Autogenous drainage of sputum caused by hypertonic saline in adolescents with cystic fibrosis.	The procedure will be performed at the same session as follows : * 30 minutes of autogenous drainage, followed by collection of secretions. * 10 minutes of HSS followed by 30 minutes of autogenous drainage before secretions are collected. The intervention first step involves verifying patient tolerance to Hypertonic saline solution nebulization (Auscultation, peak flow, saturtion levels), followed by the inhalation of 2 puffs of Ventolin® to prevent bronchospasm. Ten minutes later, the patient undergoes a 10-minute nebulization of 4 mL SSH 6% carried out according to the HAS recommendations. The patient tolerance to SSH is reassessed. If there are no adverse reactions, the patient continues the protocol. If issues like wheezing, a ≥5% drop in SpO2, or a ≥20% drop in Peak Flow occur, 4 more puffs of Ventolin® are given, and the patient is reassessed.If still intolerant, the patient exits the study. The session ends with physiotherapy (autogenous drainage) to aid mucus clearance.

Timeline

• Start date: 2021-07-20
• Primary completion: 2021-10-10
• Completion: 2021-10-10
• First posted: 2025-04-04
• Last updated: 2025-04-04

Locations

1 site across 1 country: France