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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-02-28

Brief Summary

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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".

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Detailed Description

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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.

Conditions

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Atelectasis Pneumonia Acute Respiratory Distress Syndrome Pulmonary Embolism Hypoxemia Dyspnea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Lung ultrasound examination on Day 1 and Day 2 to 4

Intervention Type PROCEDURE

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.

GE Vivid Ultrasound system

Intervention Type DEVICE

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

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.

Group Type OTHER

Lung ultrasound examination on Day 1

Intervention Type PROCEDURE

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.

GE Vivid Ultrasound system

Intervention Type DEVICE

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

Interventions

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Lung 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.

Intervention Type PROCEDURE

Lung 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.

Intervention Type PROCEDURE