NCT04057625

Brief Summary

To evaluate the sensitivity, specificity and diagnostic accuracy of bedside transthoracic ultrasound examination in the diagnosis and follow up of ventilator associated pneumonia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Status
unknown

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

August 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

August 26, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

August 14, 2019

Last Update Submit

August 22, 2019

Conditions

Ventilator Associated PneumoniaLung Ultrasound

Outcome Measures

Primary Outcomes (1)

  • detecting ultrasound efficiency in diagnosis and follow up of vap

    Sensitivity, specificity, and diagnostic accuracy of lung ultrasound to diagnose and follow up ventilator-associated pneumonia.

    baseline

Secondary Outcomes (3)

  • icu stay

    baseline

  • hospital stay

    basline

  • mortality

    basline

Study Arms (1)

lung ultrasound

OTHER

using lung ultrasound in diagnosis and follow up of vap measuring the largest area of consolidation according to intercostal space and the direction of the probe

Device: transthoracic ultrasound

Interventions

transthoracic ultrasoundDEVICE

using transthoracic ultrasound in the diagnosis and follow up of vap,measuring the largest area of consolidation according to intercostal space and the direction of the probe.

lung ultrasound

Eligibility Criteria

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

You may qualify if:

  • Mechanical ventilation for at least 48 hours.
  • New or evolving infiltrate on chest radiograph (CXR).
  • Clinical pulmonary infection score more than or equal 6

You may not qualify if:

  • Patients who are less than 18 years old.
  • Patients who have evidence of pneumonia before or prior to being mechanically ventilated.
  • Patients with pulmonary infarction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 14, 2019

First Posted

August 15, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

August 26, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share