Jet or Vibrating Mesh Nebulisation for Secretion Management in ICU

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Can Continuous or Intermittent Normal Saline Nebulisation Via a Vibrating Mesh Nebuliser or Intermittent Normal Saline Via a Standard Jet Nebuliser Improve the Lung Physiology and Secretion Viscosity in Mechanically Ventilated Patients?

Conditions
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Respiratory Failure, Critical Illness

Intervention / Treatment
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* Procedure: Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser
* Procedure: Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser
* Procedure: Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18-80 years at time of recruitment to study Ventilated via an endotracheal tube or tracheostomy with an HME filter in the circuit Secretion load defined as patient requiring suctioning at least 2 times in the 6 hours prior to recruitment Sputum viscosity with grades 1 to 3 pourability in the Qualitative Sputum Assessment tool Not yet received saline nebulisation in the 6 hours prior to recruitment Likely to be ventilated via an endotracheal tube or tracheostomy for at least 3 days in the opinion of the treating clinician Exclusion Criteria: Pregnancy Pulmonary embolus Heart Failure (NYHA Grade III/IV) Clinical evidence of frank pulmonary oedema Cardiovascular instability (systolic BP ≤75 or heart rate ≥140)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser<br>Continuous nebulization of 0.9% normal saline using the Aerogen Solo Nebuliser (50mls/24h continuous infusion using a syringe pump) | Procedure: Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser<br>* Continuous nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser<br>|
| Experimental: Intermittent nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser<br>Intermittent nebulization of 0.9% normal saline using the Aerogen Solo Nebuliser (5mls 0.9% normal saline nebulised every 6 hours) | Procedure: Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser<br>* Intermittent nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser<br>|
| Active Comparator: Intermittent standard nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser<br>Intermittent standard nebulization of 0.9% normal saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser ((5mls 0.9% normal saline nebulised every 6 hours) | Procedure: Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser<br>* standard intermittent nebulisation of 0.9% saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pourability 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 | At 1000 and 1600 for 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of secretions | Total volume in ml of secretions aspirated from the patient's airway at 1000 and 1600 each day | At 1000 and 1600 for 3 days | 
| Work of breathing | Recorded by ventilator as pressure over volume curve for each breath in joules/min | At 1000 and 1600 for 3 days | 
| Airway resistance | Recorded by the ventilator in cm H2O/L/sec at 1000 and 1600 each day | 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 | 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. | 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 | Number of filters used in each 24 hour period for 3 days | 
| Length of time on ventilator | Total number of days ventilated | 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 | Number of day in ICU and HDU at Queen Elizabeth University hospital | 
| Mortality | Alive at 28 days- Yes/NO | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nebuliser, secretions