Ventilator Associated PneumoniaSUBSUSNCT04739878
SUBSUS (SUBglottic Secretion at Ultrasound Score)
A study testing Airway Ultrasound in people with Ventilator Associated Pneumonia, run by Hospital Raja Permaisuri Bainun at 1 site in Malaysia.
Trial summary
To compare the performance of ultrasound in detecting subglottic secretion above the ETT tube cuff in comparison to computed tomography (CT) scan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Airway Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2021to 31 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age more than 18 years old
- ETT in situ
- indicated for CT cervical scan
Who cannot join
- neck subcutaneous emphysema
- neck scar or surgical dressing around the neck which can lead to difficulty in obtaining an optimal ultrasound image.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study On Novel Usage of Airway Ultrasound To Detect Subglottic Secretion Above Endotracheal Tube(ETT) Cuff
To compare the performance of ultrasound in detecting subglottic secretion above the ETT tube cuff in comparison to computed tomography (CT) scan.
Read the detailed description
Airway ultrasound will be performed at the bedside prior to CT scan in all intubated patients who fulfiled the criteria. The image of subglottic secretion was then compared to the plain CT cervical. The findings of the CT was examined by a radiologist.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Airway Ultrasound
- Keywords
- subglottic secretion, airway ultrasound, ventilator associated pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway UltrasoundProcedure or surgery
Also called Cervical CT plain
Comparison between Airway ultrasound and CT cervical
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Airway | Experimental | Ultrasound Airway for subglottic secretion Receives: Procedure: Airway Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective Study on Novel Usage of Airway Ultrasound To Detect Subglottic Secretion Above Endotracheal Tube Cuff
Compare the performance of airway ultrasound and cervical CT scan to diagnose subglottic secretion.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Jan 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Raja Permaisuri Bainun
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Adi Osman, MD, Principal investigator, Hospital Raja Permaisuri Bainun
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739878
- Sponsor's protocol ID
- 58284
- Acronym
- SUBSUS
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2021
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adi O, Fong CP, Sallehuddin RM, Ahmad AH, Sum KM, Yusof ZM, Via G, Tavazzi G. Airway ultrasound to detect subglottic secretion above endotracheal tube cuff. Ultrasound J. 2023 May 6;15(1):23. doi: 10.1186/s13089-023-00318-5.
PubMed 37148375
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study On Novel Usage of Airway Ultrasound To Detect Subglottic Secretion Above Endotracheal Tube(ETT) Cuff
- ClinicalTrials.gov ID
- NCT04739878
- Acronym / sponsor ID
- SUBSUS / 58284
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- subglottic secretion, airway ultrasound, ventilator associated pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Raja Permaisuri BainunOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Feb 2021 (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.
To compare the performance of ultrasound in detecting subglottic secretion above the ETT tube cuff in comparison to computed tomography (CT) scan.
Detailed description
Airway ultrasound will be performed at the bedside prior to CT scan in all intubated patients who fulfiled the criteria. The image of subglottic secretion was then compared to the plain CT cervical. The findings of the CT was examined by a radiologist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Airway | Experimental | Procedure: Airway UltrasoundUltrasound Airway for subglottic secretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age more than 18 years old
- ETT in situ
- indicated for CT cervical scan
Key exclusion criteria (2 listed)
- neck subcutaneous emphysema
- neck scar or surgical dressing around the neck which can lead to difficulty in obtaining an optimal ultrasound image.
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 |
|---|---|---|
| Airway UltrasoundAlso: Cervical CT plainComparison between Airway ultrasound and CT cervical | Procedure or surgery | Ultrasound Airway |
Primary outcome
Prospective Study on Novel Usage of Airway Ultrasound To Detect Subglottic Secretion Above Endotracheal Tube Cuff
Time frame: 90 days
Compare the performance of airway ultrasound and cervical CT scan to diagnose subglottic secretion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Derived from this study: PubMed 37148375Adi O, Fong CP, Sallehuddin RM, Ahmad AH, Sum KM, Yusof ZM, Via G, Tavazzi G. Airway ultrasound to detect subglottic secretion above endotracheal tube cuff. Ultrasound J. 2023 May 6;15(1):23. doi: 10.1186/s13089-023-00318-5.
- Individual participant dataSharing planned: No
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Early Identification of Pathogens in Children With Respiratory Tract Infection by Mechanical Ventilation Using mNGS
VAP - Ventilator Associated Pneumonia
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EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
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Mobile-Based Microlearning for Improving ICU Nurses' Adherence to Ventilator-Associated Pneumonia Prevention Protocols
Ventilator-Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
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.
Adi Osman, MD principal investigator
Hospital Raja Permaisuri Bainun
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway Ultrasound in people with Ventilator Associated Pneumonia, run by Hospital Raja Permaisuri Bainun at 1 site in Malaysia.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 1 Mar 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective Study on Novel Usage of Airway Ultrasound To Detect Subglottic Secretion Above Endotracheal Tube Cuff (time frame: 90 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 NCT04739878, which also lists 1 linked publication.
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 1 Mar 2023.