Jet or Vibrating Mesh Nebulisation for Secretion Management in ICU
NCT ID: NCT05635903
Last Updated: 2023-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2019-12-22
2023-12-22
Brief Summary
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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.
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser
Continuous nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser
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)
Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser
Intermittent nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser
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)
Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser
standard intermittent nebulisation of 0.9% saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser
Interventions
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Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser
Continuous nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser
Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser
Intermittent nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser
Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser
standard intermittent nebulisation of 0.9% saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser
Eligibility Criteria
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Inclusion Criteria
* 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
* Pulmonary embolus
* Heart Failure (NYHA Grade III/IV)
* Clinical evidence of frank pulmonary oedema
* Cardiovascular instability (systolic BP ≤75 or heart rate ≥140)
18 Years
80 Years
ALL
No
Sponsors
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Aerogen
INDUSTRY
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Principal Investigators
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Malcolm Sim, MBcHB
Role: PRINCIPAL_INVESTIGATOR
nhs GGC health board
Locations
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Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Thille AW, Richard JC, Brochard L. The decision to extubate in the intensive care unit. Am J Respir Crit Care Med. 2013 Jun 15;187(12):1294-302. doi: 10.1164/rccm.201208-1523CI.
Terzi N, Guerin C, Goncalves MR. What's new in management and clearing of airway secretions in ICU patients? It is time to focus on cough augmentation. Intensive Care Med. 2019 Jun;45(6):865-868. doi: 10.1007/s00134-018-5484-2. Epub 2018 Dec 5. No abstract available.
Jaber S, Quintard H, Cinotti R, Asehnoune K, Arnal JM, Guitton C, Paugam-Burtz C, Abback P, Mekontso Dessap A, Lakhal K, Lasocki S, Plantefeve G, Claud B, Pottecher J, Corne P, Ichai C, Hajjej Z, Molinari N, Chanques G, Papazian L, Azoulay E, De Jong A. Risk factors and outcomes for airway failure versus non-airway failure in the intensive care unit: a multicenter observational study of 1514 extubation procedures. Crit Care. 2018 Sep 23;22(1):236. doi: 10.1186/s13054-018-2150-6.
Keal EE, Reid L. Neuraminic acid content of sputum in chronic bronchitis. Thorax. 1972 Nov;27(6):643-53. doi: 10.1136/thx.27.6.643.
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. doi: 10.1136/thx.28.4.401.
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 2005; 4(4): 287-291.
Arnott A, Hart R, McQueen S, Watson M, Sim M. Prospective randomised unblinded comparison of sputum viscosity for three methods of saline nebulisation in mechanically ventilated patients: A pilot study protocol. PLoS One. 2023 Aug 17;18(8):e0290033. doi: 10.1371/journal.pone.0290033. eCollection 2023.
Other Identifiers
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GN18RM440
Identifier Type: -
Identifier Source: org_study_id
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