Jet or Vibrating Mesh Nebulisation for Secretion Management in ICU

Phase

N/A

Condition

Lung Injury

Respiratory Failure

Treatment

N/A

Clinical Study ID

NCT05635903

GN18RM440

Ages 18-80
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 hoursprior to recruitment
Sputum viscosity with grades 1 to 3 pourability in the Qualitative Sputum Assessmenttool
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 daysin the opinion of the treating clinician

Exclusion

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 Design

December 22, 2019

December 22, 2023

Study 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
1. 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)

Connect with a study center

Queen Elizabeth University Hospital
Glasgow,
United Kingdom
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.