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?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 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)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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)
Intervention: Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser (Procedure)
Intermittent nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser
Intermittent nebulization of 0.9% normal saline using the Aerogen Solo Nebuliser (5mls 0.9% normal saline nebulised every 6 hours)
Intervention: Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser (Procedure)
Intermittent standard 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)
Intervention: Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser (Procedure)
Outcomes
Primary Outcomes
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)
Time Frame: 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 Outcomes
- Volume of secretions(At 1000 and 1600 for 3 days)
- Ease of sampling, in the opinion of the treating nurse(At 1000 and 1600 for 3 days)
- Mortality(28 days)
- Work of breathing(At 1000 and 1600 for 3 days)
- Airway resistance(At 1000 and 1600 for 3 days)
- Length of stay in ICU(Number of day in ICU and HDU at Queen Elizabeth University hospital)
- 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)
- Frequency of requiring changing the HME filter(Number of filters used in each 24 hour period for 3 days)
- Length of time on ventilator(1 years after admission to ICU/HDU(Intensive care unit/high dependance unit))