AtelectasisNCT02100449
Role of Lung Ultrasound and Pulsed-wave Doppler in Lung Consolidations in Mechanically Ventilated Patients
A study testing Lung ultrasound and Doppler (Day 0) in people with Atelectasis and Pneumonia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
In infectious lung consolidations, the inhibition of hypoxic pulmonary vasoconstriction (HPV) results in a higher regional acceleration time (RAcT) compared to the RAcT measured in atelectatic consolidations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atelectasis, Pneumonia
- What is being tested?
- Lung ultrasound and Doppler (Day 0)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2014to 1 Nov 2024
- 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
- Under mechanical ventilation and presenting one or more consolidations on chest radiography or CT scan
Who cannot join
- Participation to another study
- Poor echogenicity (morbid obesity, multiple thoracic dressings)
- Contra-indications to superior limbs or torso mobilization
- Contra-indications to bronchoscopy
- Antibiotics initiated more than 24 hours but less than 72 hours before inclusion or changes in the antibiotic regimen in the last 72 hours.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Martin Girard, MD, FRCPC, 514-890-8000 ext. 12131, martin.girard@umontreal.ca
Pierre Aslanian, MD, FRCPC
About this study
Official title: Role of Lung Ultrasound Imaging and Pulsed-wave Doppler in the Assessment of Lung Consolidations in Mechanically Ventilated Patients.
In infectious lung consolidations, the inhibition of hypoxic pulmonary vasoconstriction (HPV) results in a higher regional acceleration time (RAcT) compared to the RAcT measured in atelectatic consolidations.
Read the detailed description
Ventilator-associated pneumonia has a considerable impact on morbidity and mortality in intensive-care patients. Chest radiography, which is the most frequently used imagery test for bedside lung evaluation in mechanically ventilated patients, is recognized to be poorly sensitive and non-specific for the diagnosis of ventilator-associated pneumonia. Bronchoalveolar lavage using a bronchoscope remains the most reliable tool for the diagnosis of this nosocomial infection. However, a bronchoscopy may not be feasible in all patients and waiting time before final results become available may cause a delay in the initiation of the treatment, thus increasing the risk of mortality. Lung ultrasound is a promising non-invasive, non-radiant, portable and easy to use tool especially in critically-ill patients.
Dependent atelectasis is a frequent phenomenon in mechanically ventilated patients. The presence of clinical infection signs raises the question of the nature of the infiltrate. A consolidation of infectious nature differs from atelectasis by its local hypoxic pulmonary vasoconstriction inhibition. In patients breathing spontaneously, it is possible to detect this difference using the RAcT, measured by pulsed-wave Doppler in an arterial blood vessel located in a pulmonary consolidation visible by ultrasound examination. The use of pulsed-wave Doppler to measure the RAcT in a consolidation added to the value of general lung ultrasound could help determine the infectious or atelectatic nature of a consolidation in mechanically ventilated patients. However, the RAcT has never been studied in patients under positive pressure ventilation. In this observational study, the investigators will explore the role of measuring the RAcT and of general lung ultrasound as a diagnostic tool to detect pneumonia in mechanically ventilated patients.
- Conditions
- Atelectasis, Pneumonia
- Being tested
- Lung ultrasound and Doppler (Day 0)
- Keywords
- Atelectasis, Pneumonia, Lung ultrasound, Doppler
- Medical subject headings
- Pulmonary Atelectasis, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound and Doppler (Day 0)Other
In patients presenting a consolidation of suspected atelectatic nature, a lung ultrasound examination using pulsed-wave Doppler will be performed on Day 0.
Lung ultrasound and Doppler (Day 0)Other
In patients presenting a consolidation of suspected infectious nature, a lung ultrasound examination using pulsed-wave Doppler will be performed on Day 0. A bronchoalveolar lavage will also be performed on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Lung ultrasound and Doppler, pneumonia | Other | In this group, a lung ultrasound examination using pulsed-wave Doppler will be performed in patients with high clinical suspicion of pneumonia on Day 0. A bronchoalveolar lavage will also be performed on Day 0. Receives: Other: Lung ultrasound and Doppler (Day 0) |
| Lung ultrasound and Doppler, atelectasis | Other | Patients without clinically active pulmonary disease but presenting a consolidation of suspected atelectatic nature. Fever, hypothermia, leucocytosis and leucopenia will not be present. Tracheal secretions will remain unchanged. There will be no deterioration of oxygenation. In this group, a lung ultrasound examination using pulsed-wave Doppler will be performed on Day 0. Receives: Other: Lung ultrasound and Doppler (Day 0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAcT in lung consolidations
Regional acceleration time measured by lung ultrasound and pulsed-wave Doppler
Measured: During lung ultrasound examination - Day 0
Secondary outcomes (3)
Presence of visible blood vessels on colour Doppler in lung consolidations
Graded semi-quantitatively (absence, single, multiple branching)
Measured: During lung ultrasound examination - Day 0
Presence of dynamic air bronchograms in lung consolidations
To-and-fro respiratory movement of punctiform or linear hyperechoic artifacts (absence or presence)
Measured: During lung ultrasound examination - Day 0
Presence of sub-pleural consolidations
Subpleural hypoechoic area with ragged margins (absence or presence)
Measured: During lung ultrasound examination - Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study start1 Jun 2014
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
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
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- 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
- NCT02100449
- Sponsor's protocol ID
- 14.005
- Status last verified
- Feb 2024
- First submitted
- 27 Mar 2014
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lung Ultrasound Imaging and Pulsed-wave Doppler in the Assessment of Lung Consolidations in Mechanically Ventilated Patients.
- ClinicalTrials.gov ID
- NCT02100449
- Acronym / sponsor ID
- 14.005
- Conditions
- Atelectasis, Pneumonia
- Keywords
- Atelectasis, Pneumonia, Lung ultrasound, Doppler
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Centre de Recherche du Centre Hospitalier de l'Université de Montréal
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 1 Apr 2014 (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.
In infectious lung consolidations, the inhibition of hypoxic pulmonary vasoconstriction (HPV) results in a higher regional acceleration time (RAcT) compared to the RAcT measured in atelectatic consolidations.
Detailed description
Ventilator-associated pneumonia has a considerable impact on morbidity and mortality in intensive-care patients. Chest radiography, which is the most frequently used imagery test for bedside lung evaluation in mechanically ventilated patients, is recognized to be poorly sensitive and non-specific for the diagnosis of ventilator-associated pneumonia. Bronchoalveolar lavage using a bronchoscope remains the most reliable tool for the diagnosis of this nosocomial infection. However, a bronchoscopy may not be feasible in all patients and waiting time before final results become available may cause a delay in the initiation of the treatment, thus increasing the risk of mortality. Lung ultrasound is a promising non-invasive, non-radiant, portable and easy to use tool especially in critically-ill patients.
Dependent atelectasis is a frequent phenomenon in mechanically ventilated patients. The presence of clinical infection signs raises the question of the nature of the infiltrate. A consolidation of infectious nature differs from atelectasis by its local hypoxic pulmonary vasoconstriction inhibition. In patients breathing spontaneously, it is possible to detect this difference using the RAcT, measured by pulsed-wave Doppler in an arterial blood vessel located in a pulmonary consolidation visible by ultrasound examination. The use of pulsed-wave Doppler to measure the RAcT in a consolidation added to the value of general lung ultrasound could help determine the infectious or atelectatic nature of a consolidation in mechanically ventilated patients. However, the RAcT has never been studied in patients under positive pressure ventilation. In this observational study, the investigators will explore the role of measuring the RAcT and of general lung ultrasound as a diagnostic tool to detect pneumonia in mechanically ventilated patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung ultrasound and Doppler, pneumonia | Other | Other: Lung ultrasound and Doppler (Day 0)In this group, a lung ultrasound examination using pulsed-wave Doppler will be performed in patients with high clinical suspicion of pneumonia on Day 0. A bronchoalveolar lavage will also be performed on Day 0. |
| Lung ultrasound and Doppler, atelectasis | Other | Other: Lung ultrasound and Doppler (Day 0)Patients without clinically active pulmonary disease but presenting a consolidation of suspected atelectatic nature. Fever, hypothermia, leucocytosis and leucopenia will not be present. Tracheal secretions will remain unchanged. There will be no deterioration of oxygenation. In this group, a lung ultrasound examination using pulsed-wave Doppler will be performed on Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Under mechanical ventilation and presenting one or more consolidations on chest radiography or CT scan
Key exclusion criteria (5 listed)
- Participation to another study
- Poor echogenicity (morbid obesity, multiple thoracic dressings)
- Contra-indications to superior limbs or torso mobilization
- Contra-indications to bronchoscopy
- Antibiotics initiated more than 24 hours but less than 72 hours before inclusion or changes in the antibiotic regimen in the last 72 hours.
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 and Doppler (Day 0)In patients presenting a consolidation of suspected atelectatic nature, a lung ultrasound examination using pulsed-wave Doppler will be performed on Day 0. | Other | Lung ultrasound and Doppler, atelectasis |
| Lung ultrasound and Doppler (Day 0)In patients presenting a consolidation of suspected infectious nature, a lung ultrasound examination using pulsed-wave Doppler will be performed on Day 0. A bronchoalveolar lavage will also be performed on Day 0. | Other | Lung ultrasound and Doppler, pneumonia |
Primary outcome
RAcT in lung consolidations
Time frame: During lung ultrasound examination - Day 0
Regional acceleration time measured by lung ultrasound and pulsed-wave Doppler
3 secondary outcomes
Presence of visible blood vessels on colour Doppler in lung consolidations
Time frame: During lung ultrasound examination - Day 0
Presence of dynamic air bronchograms in lung consolidations
Time frame: During lung ultrasound examination - Day 0
Presence of sub-pleural consolidations
Time frame: During lung ultrasound examination - Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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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 and Doppler (Day 0) 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Girard, MD, FRCPC (514-890-8000 ext. 12131, martin.girard@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RAcT in lung consolidations (time frame: During lung ultrasound examination - Day 0). 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 8 Feb 2024.