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CompletedNCT02450825Updated Mar 3, 2017

Comparison of Three Scores for Ultrasound Assessment and Monitoring of Pulmonary Aeration

An interventional study of Lung ultrasound examination on Day 1 and Day 2 to 4 and Lung ultrasound examination on Day 1 in Atelectasis, Pneumonia and Acute Respiratory Distress Syndrome, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
77
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to compare three ultrasound-based aeration scores that were previously validated in specific populations, and to assess their correlation with computed tomographic measurement of pulmonary aeration in a population with different pathologies.

Hypothesis: The "Loss of Aeration Score" will be more accurate than a simplified version and another widely used score, the "Lung Ultrasound Score".

Read the detailed description

Assessment of lung aeration may have a great impact in the management of mechanical ventilation and follow-up of diverse lung pathologies. Computed tomographic scan is the gold standard method of lung aeration measurement but is rarely used because it requires transport of critically ill patients end exposes them to radiations. For these reasons, lung ultrasound would be an attractive alternative. Variants of different ultrasound-based aeration scores have been validated in different specific populations, but there is no comparison study that defines the more accurate score that should be used in a population with different pathologies.

Methods: Patients undergoing a computed tomographic scan for dyspnea or hypoxemia will have a standardized lung ultrasound examination on Day 1. For mechanically ventilated patients only, a lung ultrasound examination will be repeated on Day 2 to 4. End expiratory lung volume will also be measured in mechanically ventilated patients on Day 1 and Day 2 to 4. Lung ultrasound images will be interpreted blindly. Correlation of ultrasound-based aeration scores will be done with lung aeration measured by computed tomographic images.

02

Conditions studied

  • Atelectasis
  • Pneumonia
  • Acute Respiratory Distress Syndrome
  • Pulmonary Embolism
  • Hypoxemia
  • Dyspnea
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 77 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Hospitalized or visiting the emergency room
  • Will undergo a computed tomographic scan for dyspnea or hypoxemia

Exclusion criteria

Exclusion Criteria:

  • Poor echogenicity (morbid obesity, multiple thoracic dressings)
  • Contraindications to superior limbs or torso mobilization
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
77 participants (actual)

Study arms

  • Other
    Mechanically ventilated patients

    Mechanically ventilated patients who underwent a computed tomographic scan for dyspnea or hypoxemia will undergo a standardized lung ultrasound examination on Day 1 and Day 2 to 4. The GE Vivid ultrasound system will be used to perform the lung ultrasound examination.

    Procedure: Lung ultrasound examination on Day 1 and Day 2 to 4 · Device: GE Vivid Ultrasound system

  • Other
    Spontaneously breathing patients

    Spontaneously breathing patients who underwent a computed tomographic scan for dyspnea or hypoxemia will undergo a standardized lung ultrasound examination on Day 1 only. The GE Vivid ultrasound system will be used to perform the lung ultrasound examination.

    Procedure: Lung ultrasound examination on Day 1 · Device: GE Vivid Ultrasound system

Interventions

  • ProcedureLung ultrasound examination on Day 1 and Day 2 to 4

    A standardized lung ultrasound examination using the GE Vivid ultrasound system will be performed following the tomographic scan on Day 1 and repeated on Day 2 to 4. Correlation of ultrasound-based aeration scores will be done with lung aeration measured by computed tomographic images.

  • ProcedureLung ultrasound examination on Day 1

    A standardized lung ultrasound examination using the GE Vivid ultrasound system will be performed following the tomographic scan on Day 1 only. Correlation of ultrasound-based aeration scores will be done with lung aeration measured by computed tomographic images.

  • DeviceGE Vivid Ultrasound system

    The GE Vivid ultrasound system will be used for all lung ultrasound examinations performed in this study.

06

What researchers measure

Primary outcomes

  1. Correlation of ultrasound-based aeration scores with computed tomographic measurement of pulmonary aeration.

    Time frame: Day 1

Secondary outcomes

  1. Correlation of ultrasound-based aeration scores and expiratory lung volume variation.

    In mechanically ventilated patients, correlation of ultrasound-based aeration scores and expiratory lung volume variation between Day 1 and Day 2 to 4 will be assessed.

    Time frame: Day 2 to Day 4

07

Study locations

1 site
  • Centre Hospitalier de l'université de Montréal (CHUM)
    Montreal, Quebec H2L 4M1, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02450825
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible party
Sponsor
First posted
May 21, 2015
Start date
Jul 2015
Primary completion
Feb 2017
Completion
Feb 2017
Last update
Mar 3, 2017

Study contacts

Martin Girard, MD, FRCPC
principal investigator · Centre hospitalier de l'Université de Montréal (CHUM)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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