Back to resultsSUBSUS (SUBglottic Secretion at Ultrasound Score) (SUBSUS)
Primary Purpose
Ventilator Associated Pneumonia
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Airway Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventilator Associated Pneumonia focused on measuring subglottic secretion, airway ultrasound, ventilator associated pneumonia
Eligibility Criteria
Inclusion Criteria:
- age more than 18 years old
- ETT in situ
- indicated for CT cervical scan
Exclusion Criteria:
- neck subcutaneous emphysema
- neck scar or surgical dressing around the neck which can lead to difficulty in obtaining an optimal ultrasound image.
Sites / Locations
- Raja Permaisuri Bainun Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound Airway
Arm Description
Ultrasound Airway for subglottic secretion
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04739878
First Posted
January 18, 2021
Last Updated
February 28, 2023
Sponsor
Hospital Raja Permaisuri Bainun
1. Study Identification
Unique Protocol Identification Number
NCT04739878
Brief Title
SUBSUS (SUBglottic Secretion at Ultrasound Score)
Acronym
SUBSUS
Official Title
Prospective Study On Novel Usage of Airway Ultrasound To Detect Subglottic Secretion Above Endotracheal Tube(ETT) Cuff
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Raja Permaisuri Bainun
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia
Keywords
subglottic secretion, airway ultrasound, ventilator associated pneumonia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound Airway
Arm Type
Experimental
Arm Description
Ultrasound Airway for subglottic secretion
Intervention Type
Procedure
Intervention Name(s)
Airway Ultrasound
Other Intervention Name(s)
Cervical CT plain
Intervention Description
Comparison between Airway ultrasound and CT cervical
Primary Outcome Measure Information:
Title
Prospective Study on Novel Usage of Airway Ultrasound To Detect Subglottic Secretion Above Endotracheal Tube Cuff
Description
Compare the performance of airway ultrasound and cervical CT scan to diagnose subglottic secretion.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age more than 18 years old
ETT in situ
indicated for CT cervical scan
Exclusion Criteria:
neck subcutaneous emphysema
neck scar or surgical dressing around the neck which can lead to difficulty in obtaining an optimal ultrasound image.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adi Osman, MD
Organizational Affiliation
Hospital Raja Permaisuri Bainun
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raja Permaisuri Bainun Hospital
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30400
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SUBSUS (SUBglottic Secretion at Ultrasound Score)
We'll reach out to this number within 24 hrs