Clinical trial NCT05635903: Jet or Vibrating Mesh Nebulisation for Secretion Management in ICU
Official title: 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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Critical Illness
Keywords: nebuliser
secretions
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: Aerogen
First posted: 2022-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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)

Primary outcomes:
measure: 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)
timeFrame: At 1000 and 1600 for 3 days
Secondary outcomes:
measure: Volume of secretions
timeFrame: At 1000 and 1600 for 3 days
measure: Work of breathing
timeFrame: At 1000 and 1600 for 3 days
measure: Airway resistance
timeFrame: At 1000 and 1600 for 3 days
measure: Number of number of additional nebulised doses of saline or other drugs administered during the study period
timeFrame: Number of administer nebulised drugs per 24hour per
measure: Ease of sampling, in the opinion of the treating nurse
timeFrame: At 1000 and 1600 for 3 days
measure: Frequency of requiring changing the HME filter
timeFrame: Number of filters used in each 24 hour period for 3 days
measure: Length of time on ventilator
timeFrame: 1 years after admission to ICU/HDU(Intensive care unit/high dependance unit)
measure: Length of stay in ICU
timeFrame: Number of day in ICU and HDU at Queen Elizabeth University hospital
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: nhs GGC health board
name: Malcolm Sim, MBcHB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 2005; 4(4): 287-291.