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

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".

Study Overview

• Status: Completed
• Conditions: Pneumonia; Acute Respiratory Distress Syndrome; Pulmonary Embolism; Dyspnea; Hypoxemia; Atelectasis
• Intervention / Treatment: Procedure: Lung ultrasound examination on Day 1 and Day 2 to 4; Device: GE Vivid Ultrasound system; Procedure: Lung ultrasound examination on Day 1

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Device: GE Vivid Ultrasound system; The GE Vivid ultrasound system will be used for all lung ultrasound examinations performed in this study.
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.	Device: GE Vivid Ultrasound system; The GE Vivid ultrasound system will be used for all lung ultrasound examinations performed in this study.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation of ultrasound-based aeration scores with computed tomographic measurement of pulmonary aeration.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: May 12, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Embolism and Thrombosis; Signs and Symptoms, Respiratory; Lung Injury; Infant, Premature, Diseases; Pulmonary Atelectasis; Embolism; Hypoxia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pulmonary Embolism; Dyspnea
• Other Study ID Numbers: 15.012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO