Jet or Vibrating Mesh Nebulisation for Secretion Management in ICU

NCT05635903 | Unknown

• 1 other identifier: GN18RM440
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Critical Illness

Keywords

nebuliser; secretions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Volume of secretions

  At 1000 and 1600 for 3 days

• Work of breathing

  At 1000 and 1600 for 3 days

• Airway resistance

  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 administer nebulised drugs per 24hour per

• Ease of sampling, in the opinion of the treating nurse

  At 1000 and 1600 for 3 days

Study Arms (3)

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)

Procedure: Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser

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)

Procedure: Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser

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)

Procedure: Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser

Interventions

Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser PROCEDURE

Continuous nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser

Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser

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 nebulisation 0.9% saline 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

Intermittent standard nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Pulmonary embolus
• Heart Failure (NYHA Grade III/IV)
• Clinical evidence of frank pulmonary oedema
• Cardiovascular instability (systolic BP ≤75 or heart rate ≥140)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• Aerogen: collaborator

Study Sites (1)

Queen Elizabeth University Hospital

Glasgow, United Kingdom

RECRUITING

Related Publications (7)

• 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.

  PMID: 23641924 BACKGROUND

• 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.

  PMID: 30519901 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.

  PMID: 30243304 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.

  PMID: 4647626 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.

  PMID: 4741442 RESULT

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

  RESULT

• 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.

  PMID: 37590203 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Critical Illness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Malcolm Sim, MBcHB

  nhs GGC health board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

malcolm SIm, MBChB

CONTACT

01414523430; malcolm.sim@ggc.scot.nhs.uk

malcolm watson, MBCHB

CONTACT

01414523430; malcolm.watson@ggc.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: December 2, 2022
• Study Start: December 22, 2019
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)