SUBSUS (SUBglottic Secretion at Ultrasound Score) (SUBSUS)

February 28, 2023 updated by: Hospital Raja Permaisuri Bainun

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Perak
      • Ipoh, Perak, Malaysia, 30400
        • Raja Permaisuri Bainun Hospital
        • Contact:
          • Philip Rajan Devesahayam, MD
          • Phone Number: +6052085147
        • Principal Investigator:
          • Osman Adi, MD
        • Sub-Investigator:
          • Azma Haryaty Ahmad, MBBCHBAO
        • Sub-Investigator:
          • Chan Pei Fong, MD
        • Sub-Investigator:
          • Azlizawati Azil, MBBCHBAO
        • Sub-Investigator:
          • Roslanuddin Salehuddin, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound Airway
Ultrasound Airway for subglottic secretion
Procedure: Airway Ultrasound
Comparison between Airway ultrasound and CT cervical
Other Names:
  • Cervical CT plain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Raja Permaisuri Bainun

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

January 18, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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