Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-26 @ 10:49 PM
Study NCT ID:
NCT05635903
Status:
UNKNOWN
Last Update Posted:
2023-02-02
First Post:
2022-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Jet or Vibrating Mesh Nebulisation for Secretion Management in ICU
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
Study Overview
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?
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: