Jet or Vibrating Mesh Nebulisation for Secretion Management in ICU
- Conditions
- Respiratory FailureCritical Illness
- Interventions
- Procedure: Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo NebuliserProcedure: Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh NebuliserProcedure: Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser
- Registration Number
- NCT05635903
- Lead Sponsor
- NHS Greater Glasgow and Clyde
- Brief Summary
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
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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- Pregnancy
- Pulmonary embolus
- Heart Failure (NYHA Grade III/IV)
- Clinical evidence of frank pulmonary oedema
- Cardiovascular instability (systolic BP ≤75 or heart rate ≥140)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser Intermittent nebulization of 0.9% normal saline using the Aerogen Solo Nebuliser (5mls 0.9% normal saline nebulised every 6 hours) Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser Continuous nebulization of 0.9% normal saline using the Aerogen Solo Nebuliser (50mls/24h continuous infusion using a syringe pump) Intermittent standard nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser 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)
- Primary Outcome Measures
Name Time Method 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) At 1000 and 1600 for 3 days 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
- Secondary Outcome Measures
Name Time Method Volume of secretions At 1000 and 1600 for 3 days Total volume in ml of secretions aspirated from the patient's airway at 1000 and 1600 each day
Ease of sampling, in the opinion of the treating nurse At 1000 and 1600 for 3 days Qualitative assessment scale 1-10 . 1 very easy to sample-10 very difficult to obtain a sputum sample.
Mortality 28 days Alive at 28 days- Yes/NO
Work of breathing At 1000 and 1600 for 3 days Recorded by ventilator as pressure over volume curve for each breath in joules/min
Airway resistance At 1000 and 1600 for 3 days Recorded by the ventilator in cm H2O/L/sec at 1000 and 1600 each day
Length of stay in ICU Number of day in ICU and HDU at Queen Elizabeth University hospital Length of stay in ICU in days
Number of number of additional nebulised doses of saline or other drugs administered during the study period Number of administer nebulised drugs per 24hour per Number of nebulized drug doses of drugs administered excluding study drugs
Frequency of requiring changing the HME filter Number of filters used in each 24 hour period for 3 days Number of HME(heat moisture exchange) filter changes in the previous 24-hour period
Length of time on ventilator 1 years after admission to ICU/HDU(Intensive care unit/high dependance unit) Total number of days ventilated
Trial Locations
- Locations (1)
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom