Jet or Vibrating Mesh Nebulisation for Secretion Management in ICU

Critical Illness Clinical Trial

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05635903
• Other study ID #: GN18RM440
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2019
• Est. completion date: December 22, 2023

Study information

• Verified date: January 2023
• Source: NHS Greater Glasgow and Clyde
• Contact: malcolm SIm, MBChB
• Phone: 01414523430
• Email: malcolm.sim[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth University Hospital	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	Aerogen

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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. R — View Citation

Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 2005; 4(4): 287-291.

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. — View 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. — View 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 abstrac — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Work of breathing	Recorded by ventilator as pressure over volume curve for each breath in joules/min	At 1000 and 1600 for 3 days
Secondary	Airway resistance	Recorded by the ventilator in cm H2O/L/sec at 1000 and 1600 each day	At 1000 and 1600 for 3 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of time on ventilator	Total number of days ventilated	1 years after admission to ICU/HDU(Intensive care unit/high dependance unit)
Secondary	Length of stay in ICU	Length of stay in ICU in days	Number of day in ICU and HDU at Queen Elizabeth University hospital
Secondary	Mortality	Alive at 28 days- Yes/NO	28 days