- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07722377
Effect of Continuous Nebulisation of Isotonic Saline Solution Combined With Heated Humidification on Mucociliary Clearance in Healthy Subjects (PHYSIOCLEAR)
Mucociliary clearance is an essential defense mechanism of the lungs that helps remove inhaled particles, pathogens, and airway secretions. This process depends on the coordinated action of cilia, mucus properties, and airway hydration. In healthy individuals, mucus is continuously transported toward the throat, allowing effective clearance of harmful substances. However, this mechanism can be influenced by the hydration status of the airway surface liquid.
Heated humidification delivered through high-flow nasal cannula (HFNC) has been shown to improve airway hydration, enhance ciliary function, and support mucociliary clearance. In addition, nebulized saline solutions are commonly used to modify mucus properties. Hypertonic saline has demonstrated short-term benefits in improving mucus hydration and clearance, but its use may be associated with side effects such as airway irritation or bronchoconstriction. In contrast, the effects of isotonic saline remain unclear, particularly when delivered in large volumes.
The rationale of this study is that continuous nebulization of isotonic saline, when combined with heated humidification, may provide a sufficient cumulative amount of sodium to improve airway hydration and mucociliary clearance, potentially mimicking the effects of hypertonic saline without its adverse effects.
This study is a randomized controlled cross-over trial conducted in healthy adult volunteers. Each participant will undergo three experimental sessions: a baseline assessment without intervention, a control condition with heated humidification alone, and an intervention condition combining heated humidification with continuous isotonic saline nebulization. The order of the control and intervention sessions will be randomized.
Mucociliary clearance will be assessed using pulmonary scintigraphy. Participants will inhale radiolabeled aerosol particles (99mTc-DTPA), and the clearance of these particles from the lungs will be monitored over time using a gamma camera. Images will be acquired at regular intervals to quantify the rate of particle retention and clearance under each condition.
The primary objective of the study is to determine whether continuous isotonic saline nebulization combined with heated humidification improves mucociliary clearance compared to heated humidification alone.
Secondary outcomes include the evolution of mucociliary clearance over time during and after the intervention, as well as participant comfort assessed using a Likert scale.
The findings of this study may help improve understanding of airway hydration strategies and contribute to optimizing respiratory care techniques aimed at enhancing mucus clearance.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Brussels, Belgien, 1200
- Cliniques universitaires Saint-Luc
-
Kontakt:
- Christophe Thibon
- Telefonnummer: +32 764 16 23
- E-post: christophe.thibon@saintluc.uclouvain.be
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- >18 years old
- healthy spiromètry
Exclusion Criteria:
- <18 years old
- Pathologic spiromètry
- Active smokers
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Baslinje
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Aktiv komparator: Befuktning
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gas heated humidification through HFNC
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Experimentell: Humidification + nebulization
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gas heated humidification through HFNC
0.9 % Saline continuous nebulization
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mucociliary clearance
Tidsram: 20 minutes interval from the onset through study completion 2 hours
|
Mucociliary clearance will be assessed using biplane scintigraphy
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20 minutes interval from the onset through study completion 2 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Confort during the use of the device
Tidsram: At study completion 2 hours
|
The comfort while using the device will be assessed using a Lickert Scale
|
At study completion 2 hours
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2026/09FEV/074
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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