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

Primary Purpose

Atelectasis, Pneumonia, Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lung ultrasound examination on Day 1 and Day 2 to 4
Lung ultrasound examination on Day 1
GE Vivid Ultrasound system
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atelectasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Centre Hospitalier de l'université de Montréal (CHUM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Mechanically ventilated patients

Spontaneously breathing patients

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
May 12, 2015
Last Updated
February 28, 2017
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT02450825
Brief Title
Comparison of Three Scores for Ultrasound Assessment and Monitoring of Pulmonary Aeration
Official Title
Comparison of Three Scores for Ultrasound Assessment and Monitoring of Pulmonary Aeration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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".
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Pneumonia, Acute Respiratory Distress Syndrome, Pulmonary Embolism, Hypoxemia, Dyspnea

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mechanically ventilated patients
Arm Type
Other
Arm Description
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.
Arm Title
Spontaneously breathing patients
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lung ultrasound examination on Day 1 and Day 2 to 4
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Lung ultrasound examination on Day 1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
GE Vivid Ultrasound system
Intervention Description
The GE Vivid ultrasound system will be used for all lung ultrasound examinations performed in this study.
Primary Outcome Measure Information:
Title
Correlation of ultrasound-based aeration scores with computed tomographic measurement of pulmonary aeration.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Correlation of ultrasound-based aeration scores and expiratory lung volume variation.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized or visiting the emergency room Will undergo a computed tomographic scan for dyspnea or hypoxemia Exclusion Criteria: Poor echogenicity (morbid obesity, multiple thoracic dressings) Contraindications to superior limbs or torso mobilization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Girard, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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