Prospective randomised unblinded comparison of sputum viscosity for three methods of saline nebulisation in mechanically ventilated patients: A pilot study protocol

INTRODUCTION: Heat and moisture exchanger (HME) filters are commonly used as passive circuit humidifiers during mechanical ventilation, however, are only ~80% efficient. As a result, patients that undergo mechanical ventilation in critical care with HME filter circuits will be exposed to partial airway humidification. This is associated with detrimental effects including increased secretion load which has been shown to be an independent predictor of failed extubation. Nebulised normal saline is commonly utilised to supplement circuit humidification in ventilated patients with high secretion loads, although there are no randomised control trials evaluating its use. Novel vibrating mesh nebulisers generate a fine aerosol resulting in deeper lung penetration, potentially offering a more effective means of nebulisation in comparison to jet nebulisers. The primary aim of this study is to compare the viscosity of respiratory secretions after treatment with nebulised normal saline administered via vibrating mesh nebuliser or jet nebuliser. METHODS AND ANALYSIS: This randomised controlled trial is enrolling 60 mechanically ventilated adult critical care patients breathing on HME filter circuits with high secretion loads. Recruited patients will be randomised to receive nebulised saline via 3 modalities: 1) Continuous vibrating mesh nebuliser; 2) Intermittent vibrating mesh nebuliser or 3) Intermittent jet nebuliser. Over the 72-hr study period, the patients’ sputum viscosity (measured using a validated qualitative sputum assessment tool) and physiological parameters will be recorded by an unblinded assessor. A median reduction in secretion viscosity of ≥0.5 on the qualitative sputum assessment score will be deemed as a clinically significant improvement between treatment groups at analysis. DISCUSSION: At the conclusion of this trial, we will provisionally determine if nebulised normal saline administered via vibrating mesh nebulisation is superior to traditional jet nebulisation in terms of reduced respiratory secretion viscosity in intubated patients. Results from this pilot study will provide information to power a definitive clinical study. TRIAL REGISTRATION: ClinicalTrails.Gov Registry (NCT05635903).