Jet or Vibrating Mesh Nebulisation for Secretion Management in ICU

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?

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Respiratory Failure
• Intervention / Treatment: Procedure: Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser; Procedure: Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser; Procedure: Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser

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)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: malcolm SIm, MBChB; Phone Number: 01414523430; Email: malcolm.sim@ggc.scot.nhs.uk
• Study Contact Backup: Name: malcolm watson, MBCHB; Phone Number: 01414523430; Email: malcolm.watson@ggc.scot.nhs.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Recruiting
    • Queen Elizabeth University Hospital
    • Contact: Malcolm Sim, MB ChB; Phone Number: 01414523430; Email: malcolm.sim@ggc.scot.nhs.uk
    • Contact: Malcolm j watson, MBchB; Phone Number: 01414523430; Email: mwatson@doctors.org.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Procedure: Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser; Continuous nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser
Experimental: 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)	Procedure: Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser; Intermittent nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser
Active Comparator: 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)	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: Aerogen
• Investigators: Principal Investigator: Malcolm Sim, MBcHB, nhs GGC health board

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2019
• Primary Completion (Anticipated): December 22, 2023
• Study Completion (Anticipated): December 22, 2023

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: secretions; nebuliser
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Respiratory Insufficiency; Critical Illness; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diazepam
• Other Study ID Numbers: GN18RM440

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No