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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450825
• Other study ID #: 15.012
• Status: Completed
• Phase: N/A
• First received: May 12, 2015
• Last updated: February 28, 2017
• Start date: July 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Anoxia
• Atelectasis
• Dyspnea
• Embolism
• Hypoxemia
• Pneumonia
• Pulmonary Atelectasis
• Pulmonary Embolism
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• 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.
• 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.

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

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'université de Montréal (CHUM)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of ultrasound-based aeration scores with computed tomographic measurement of pulmonary aeration.		Day 1
Secondary	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.	Day 2 to Day 4