Critically unwell patients in Intensive Care have a decreased ability to effectively clear secretions. High secretion load is a major risk factor in the failure of tracheal extubation failure and the requirement for reintubation. Extubation failure is a predictor of poor outcome independent of the severity of the underlying illness. Nebulisation of isotonic saline can be employed to manage secretions by reducing the secretion viscosity and facilitating clearance of respiratory sections during tracheal suction. Standard jet nebulisers have been the mainstay of respiratory section management therapy in critical care since the early 1990s. A more recent development has been the vibrating mesh nebuliser. There is evidence of improved humidification and reduced water particle size and theoretically better transfer to the distal airways.
1.2 Rationale The vibrating mesh nebuliser (Aerogen technology) may be superior to standard nebuliser technology. 1.3 Study hypothesis Improved secretion management with reduced tenacity of respiratory sections and potentially improved lung physiology secondary to improved humidification or reduced size of nebulised particles? 2. STUDY OBJECTIVES Primary Endpoint Pourability of respiratory secretions (As assessed by the Qualitative Sputum Assessment Tool) (The QSA score will assess quantity, quality/stickiness/density and colour/appearance of secretions and is described and validated in the literature3,4) Secondary endpoints * Volume of secretions (increased or decreased may be beneficial) * Work of breathing * Airway resistance * Number of number of additional nebulised doses of saline or other drugs administered during the study period * Ease of sampling, in the opinion of treating nurse * Frequency of requiring changing the HME(heat and moisture exchange) filter * Length of time on ventilator * Length of stay in ICU/HDU(Intensive care unit/high dependancy unit) * ICU Mortality 3\. STUDY DESIGN 3.1 Study Population A total of 60 patients will be recruited to the study. Each patient will be randomised to receive: Continuous nebulisation of 0.9% normal saline using the Aerogen Solo Nebuliser (50mls/24h via a syringe feed set) OR Intermittent nebulisation of 0.9% normal saline using the Aerogen Solo Nebuliser (5mls, 6 hourly) OR Intermittent standard nebulisation of 0.9% normal saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser (5 mls, 6 hourly)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Continuous nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser
Intermittent nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser
standard intermittent nebulisation of 0.9% saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser
Queen Elizabeth University Hospital
Glasgow, United Kingdom
RECRUITINGPourability of respiratory secretions (The QSA score will assess quantity, quality/stickiness/density and colour/appearance of secretions and is described and validated in the literature3,4)
Pourability of respiratory secretions as assessed by the QSA (Qualitative Sputum Assessment) Tool 0-4. . As the QSA Tool score ranges from 1 to 4 in increments of 0.5, with 1 being the most pourable and 4 the least pourable. (The QSA score will assess quantity, quality/stickiness/density and colour/appearance of secretions and is described and validated Lopez-Vidriero MT, Charman J, Keal E, De Silva DJ, Reid L. Sputum viscosity: correlation with chemical and clinical features in chronic bronchitis. Thorax. 1973 Jul;28(4):401-8. PubMed ID: 4741442
Time frame: At 1000 and 1600 for 3 days
Volume of secretions
Total volume in ml of secretions aspirated from the patient's airway at 1000 and 1600 each day
Time frame: At 1000 and 1600 for 3 days
Work of breathing
Recorded by ventilator as pressure over volume curve for each breath in joules/min
Time frame: At 1000 and 1600 for 3 days
Airway resistance
Recorded by the ventilator in cm H2O/L/sec at 1000 and 1600 each day
Time frame: At 1000 and 1600 for 3 days
Number of number of additional nebulised doses of saline or other drugs administered during the study period
Number of nebulized drug doses of drugs administered excluding study drugs
Time frame: Number of administer nebulised drugs per 24hour per
Ease of sampling, in the opinion of the treating nurse
Qualitative assessment scale 1-10 . 1 very easy to sample-10 very difficult to obtain a sputum sample.
Time frame: At 1000 and 1600 for 3 days
Frequency of requiring changing the HME filter
Number of HME(heat moisture exchange) filter changes in the previous 24-hour period
Time frame: Number of filters used in each 24 hour period for 3 days
Length of time on ventilator
Total number of days ventilated
Time frame: 1 years after admission to ICU/HDU(Intensive care unit/high dependance unit)
Length of stay in ICU
Length of stay in ICU in days
Time frame: Number of day in ICU and HDU at Queen Elizabeth University hospital
Mortality
Alive at 28 days- Yes/NO
Time frame: 28 days
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