Respiratory FailureNCT05635903
Jet or Vibrating Mesh Nebulisation for Secretion Management in ICU
A study testing Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser, Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser and Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser in people with Respiratory Failure and Critical Illness, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Failure, Critical Illness
- What is being tested?
- Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser, Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser and Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Dec 2019to 22 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Pulmonary embolus
- Heart Failure (NYHA Grade III/IV)
- Clinical evidence of frank pulmonary oedema
- Cardiovascular instability (systolic BP ≤75 or heart rate ≥140)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital
Glasgow
Malcolm Sim, MB ChB, 01414523430, malcolm.sim@ggc.scot.nhs.uk
Malcolm j watson, MBchB, 01414523430, mwatson@doctors.org.uk
About this study
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?
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.
Read the 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
- 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)
- Conditions
- Respiratory Failure, Critical Illness
- Being tested
- Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser, Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser, Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser
- Keywords
- nebuliser, secretions
- Medical subject headings
- Respiratory Insufficiency, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh NebuliserProcedure or surgery
Continuous nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser
Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo NebuliserProcedure or surgery
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 NebuliserProcedure or surgery
standard intermittent nebulisation of 0.9% saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Procedure: Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 1000 and 1600 for 3 days
Secondary outcomes (9)
Volume of secretions
Total volume in ml of secretions aspirated from the patient's airway at 1000 and 1600 each day
Measured: At 1000 and 1600 for 3 days
Work of breathing
Recorded by ventilator as pressure over volume curve for each breath in joules/min
Measured: At 1000 and 1600 for 3 days
Airway resistance
Recorded by the ventilator in cm H2O/L/sec at 1000 and 1600 each day
Measured: 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
Measured: 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.
Measured: 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
Measured: Number of filters used in each 24 hour period for 3 days
Length of time on ventilator
Total number of days ventilated
Measured: 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
Measured: Number of day in ICU and HDU at Queen Elizabeth University hospital
Mortality
Alive at 28 days- Yes/NO
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start22 Dec 2019
- Primary completion22 Dec 2023 (estimated)
- Study completion22 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- Aerogen
- Responsible party
- Sponsor
- Investigators
- Malcolm Sim, MBcHB, Principal investigator, nhs GGC health board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635903
- Sponsor's protocol ID
- GN18RM440
- Status last verified
- Jan 2023
- First submitted
- 19 Oct 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23641924Terzi 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.
PubMed 30519901Jaber 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.
PubMed 30243304Keal 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.
PubMed 4647626Lopez-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.
PubMed 4741442Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 2005; 4(4): 287-291.
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.
PubMed 37590203
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT05635903
- Acronym / sponsor ID
- GN18RM440
- Conditions
- Respiratory Failure, Critical Illness
- Keywords
- nebuliser, secretions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- Aerogen
- Study start
- 22 Dec 2019 (actual)
- Primary completion
- 22 Dec 2023 (estimated)
- Study completion
- 22 Dec 2023 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser | Experimental | Procedure: Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh NebuliserContinuous nebulization of 0.9% normal saline using the Aerogen Solo Nebuliser (50mls/24h continuous infusion using a syringe pump) |
| Intermittent nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser | Experimental | Procedure: Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo NebuliserIntermittent nebulization of 0.9% normal saline using the Aerogen Solo Nebuliser (5mls 0.9% normal saline nebulised every 6 hours) |
| Intermittent standard nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser | Active comparator | Procedure: Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet NebuliserIntermittent 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy
- Pulmonary embolus
- Heart Failure (NYHA Grade III/IV)
- Clinical evidence of frank pulmonary oedema
- Cardiovascular instability (systolic BP ≤75 or heart rate ≥140)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh NebuliserContinuous nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser | Procedure or surgery | Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser |
| Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo NebuliserIntermittent nebulisation of 0.9% saline using the Aerogen Solo vibrating mesh nebuliser | Procedure or surgery | Intermittent nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser |
| Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliserstandard intermittent nebulisation of 0.9% saline using the Intersurgical Cirrus 2 self-sealing Jet Nebuliser | Procedure or surgery | Intermittent standard nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser |
Primary outcome
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)
Time frame: At 1000 and 1600 for 3 days
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
9 secondary outcomes
Volume of secretions
Time frame: At 1000 and 1600 for 3 days
Work of breathing
Time frame: At 1000 and 1600 for 3 days
Airway resistance
Time frame: At 1000 and 1600 for 3 days
Number of number of additional nebulised doses of saline or other drugs administered during the study period
Time frame: Number of administer nebulised drugs per 24hour per
Ease of sampling, in the opinion of the treating nurse
Time frame: At 1000 and 1600 for 3 days
Frequency of requiring changing the HME filter
Time frame: Number of filters used in each 24 hour period for 3 days
Length of time on ventilator
Time frame: 1 years after admission to ICU/HDU(Intensive care unit/high dependance unit)
Length of stay in ICU
Time frame: Number of day in ICU and HDU at Queen Elizabeth University hospital
Mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Background: PubMed 23641924Thille 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.
- Results publication: PubMed 30519901Terzi 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.
- Results publication: PubMed 30243304Jaber 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.
- Results publication: PubMed 4647626Keal 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.
- Results publication: PubMed 4741442Lopez-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.
- Results publicationJulious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 2005; 4(4): 287-291.
- Derived from this study: PubMed 37590203Arnott 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Sim, MBcHB principal investigator
nhs GGC health board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous nebulisation 0.9% saline Aerogen Solo vibrating mesh Nebuliser, Intermittent nebulisation 0.9% saline Aerogen vibrating mesh Solo Nebuliser and Intermittent standard intermittent nebulisation of 0.9% saline Intersurgical Cirrus 2 self sealing Jet Nebuliser in people with Respiratory Failure and Critical Illness, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact malcolm SIm, MBChB (01414523430, malcolm.sim@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: At 1000 and 1600 for 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05635903, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.