AtelectasisNCT02450825
Comparison of Three Scores for Ultrasound Assessment and Monitoring of Pulmonary Aeration
A study testing Lung ultrasound examination on Day 1 and Day 2 to 4, Lung ultrasound examination on Day 1 and GE Vivid Ultrasound system in people with Atelectasis and Pneumonia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis, Pneumonia, Acute Respiratory Distress Syndrome
- What is being tested?
- Lung ultrasound examination on Day 1 and Day 2 to 4, Lung ultrasound examination on Day 1 and GE Vivid Ultrasound system
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized or visiting the emergency room
- Will undergo a computed tomographic scan for dyspnea or hypoxemia
Who cannot join
- Poor echogenicity (morbid obesity, multiple thoracic dressings)
- Contraindications to superior limbs or torso mobilization
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
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".
Read the 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.
- Conditions
- Atelectasis, Pneumonia, Acute Respiratory Distress Syndrome, Pulmonary Embolism, Hypoxemia, Dyspnea
- Being tested
- Lung ultrasound examination on Day 1 and Day 2 to 4, Lung ultrasound examination on Day 1, GE Vivid Ultrasound system
- Medical subject headings
- Pulmonary Atelectasis, Pneumonia, Respiratory Distress Syndrome, Pulmonary Embolism, Hypoxia, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound examination on Day 1 and Day 2 to 4Procedure or surgery
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 1Procedure or surgery
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 systemDevice
The GE Vivid ultrasound system will be used for all lung ultrasound examinations performed in this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Lung ultrasound examination on Day 1 and Day 2 to 4; Device: 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. Receives: Procedure: Lung ultrasound examination on Day 1; Device: GE Vivid Ultrasound system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of ultrasound-based aeration scores with computed tomographic measurement of pulmonary aeration.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 2 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Girard, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450825
- Sponsor's protocol ID
- 15.012
- Status last verified
- Feb 2017
- First submitted
- 12 May 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Scores for Ultrasound Assessment and Monitoring of Pulmonary Aeration
- ClinicalTrials.gov ID
- NCT02450825
- Acronym / sponsor ID
- 15.012
- Conditions
- Atelectasis, Pneumonia, Acute Respiratory Distress Syndrome, Pulmonary Embolism, Hypoxemia, Dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated patients | Other | Procedure: Lung ultrasound examination on Day 1 and Day 2 to 4, Device: GE Vivid Ultrasound systemMechanically 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 | Other | Procedure: Lung ultrasound examination on Day 1, Device: GE Vivid Ultrasound systemSpontaneously 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized or visiting the emergency room
- Will undergo a computed tomographic scan for dyspnea or hypoxemia
Key exclusion criteria (2 listed)
- Poor echogenicity (morbid obesity, multiple thoracic dressings)
- Contraindications to superior limbs or torso mobilization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasound examination on Day 1 and Day 2 to 4A 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. | Procedure or surgery | Mechanically ventilated patients |
| Lung ultrasound examination on Day 1A 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. | Procedure or surgery | Spontaneously breathing patients |
| GE Vivid Ultrasound systemThe GE Vivid ultrasound system will be used for all lung ultrasound examinations performed in this study. | Device | Mechanically ventilated patients, Spontaneously breathing patients |
Primary outcome
Correlation of ultrasound-based aeration scores with computed tomographic measurement of pulmonary aeration.
Time frame: Day 1
1 secondary outcome
Correlation of ultrasound-based aeration scores and expiratory lung volume variation.
Time frame: Day 2 to Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Atelectasis
Recruiting
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Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
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Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
Not yet recruiting
Brief Bronchial Suction for Lung Collapse During Uniportal VATS
Lung Collapse, One-lung Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Girard, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung ultrasound examination on Day 1 and Day 2 to 4, Lung ultrasound examination on Day 1 and GE Vivid Ultrasound system in people with Atelectasis and Pneumonia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of ultrasound-based aeration scores with computed tomographic measurement of pulmonary aeration. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.