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| Name | Class |
|---|---|
| Aerogen | INDUSTRY |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser | Experimental | Continuous nebulization of 0.9% normal saline using the Aerogen Solo Nebuliser (50mls/24h continuous infusion using a syringe pump) |
|
| Intermittent nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser | Experimental | Intermittent nebulization of 0.9% normal saline using the Aerogen Solo Nebuliser (5mls 0.9% normal saline nebulised every 6 hours) |
|
| Intermittent standard nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser | Procedure | Continuous nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| malcolm SIm, MBChB | Contact | 01414523430 | malcolm.sim@ggc.scot.nhs.uk | |
| malcolm watson, MBCHB | Contact | 01414523430 | malcolm.watson@ggc.scot.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Malcolm Sim, MBcHB | nhs GGC health board | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth University Hospital | Recruiting | Glasgow | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23641924 | Background | 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. | |
| 30519901 | Result | 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. |
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| Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser | Procedure | 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 | Procedure | standard intermittent nebulisation of 0.9% saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser |
|
| 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 |
| 30243304 | Result | 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. |
| 4647626 | Result | 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. |
| 4741442 | Result | 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. |
| Result | Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 2005; 4(4): 287-291. |
| 37590203 | Derived | 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. |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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