NCT04739878

Brief Summary

To compare the performance of ultrasound in detecting subglottic secretion above the ETT tube cuff in comparison to computed tomography (CT) scan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

January 18, 2021

Last Update Submit

February 28, 2023

Conditions

Ventilator Associated Pneumonia

Keywords

subglottic secretionairway ultrasoundventilator associated pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days

Study Arms (1)

Ultrasound Airway

EXPERIMENTAL

Ultrasound Airway for subglottic secretion

Procedure: Airway Ultrasound

Interventions

Airway UltrasoundPROCEDURE

Comparison between Airway ultrasound and CT cervical

Also known as: Cervical CT plain
Ultrasound Airway

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age more than 18 years old
  • ETT in situ
  • indicated for CT cervical scan

You may not qualify if:

  • neck subcutaneous emphysema
  • neck scar or surgical dressing around the neck which can lead to difficulty in obtaining an optimal ultrasound image.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raja Permaisuri Bainun Hospital

Ipoh, Perak, 30400, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 37148375DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Adi Osman, MD

    Hospital Raja Permaisuri Bainun

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2021

First Posted

February 5, 2021

Study Start

March 1, 2021

Primary Completion

January 31, 2022

Study Completion

August 31, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)