NCT02450825

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

May 12, 2015

Last Update Submit

February 28, 2017

Conditions

AtelectasisPneumoniaAcute Respiratory Distress SyndromePulmonary EmbolismHypoxemiaDyspnea

Outcome Measures

Primary Outcomes (1)

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

    Day 1

Secondary Outcomes (1)

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

    Day 2 to Day 4

Study Arms (2)

Mechanically ventilated patients

OTHER

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 4Device: GE Vivid Ultrasound system

Spontaneously breathing patients

OTHER

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 1Device: GE Vivid Ultrasound system

Interventions

Lung ultrasound examination on Day 1 and Day 2 to 4PROCEDURE

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.

Mechanically ventilated patients
Lung ultrasound examination on Day 1PROCEDURE

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.

Spontaneously breathing patients
GE Vivid Ultrasound systemDEVICE

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

Mechanically ventilated patientsSpontaneously breathing patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Pulmonary AtelectasisPneumoniaRespiratory Distress SyndromePulmonary EmbolismHypoxiaDyspnea

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsInfectionsRespiration DisordersEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Girard, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 21, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)