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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02100449
Other study ID # 14.005
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2014
Est. completion date November 1, 2024

Study information

Verified date February 2024
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact Martin Girard, MD, FRCPC
Phone 514-890-8000
Email martin.girard@umontreal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Under mechanical ventilation and presenting one or more consolidations on chest radiography or CT scan Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary RAcT in lung consolidations Regional acceleration time measured by lung ultrasound and pulsed-wave Doppler During lung ultrasound examination - Day 0
Secondary Presence of visible blood vessels on colour Doppler in lung consolidations Graded semi-quantitatively (absence, single, multiple branching) During lung ultrasound examination - Day 0
Secondary Presence of dynamic air bronchograms in lung consolidations To-and-fro respiratory movement of punctiform or linear hyperechoic artifacts (absence or presence) During lung ultrasound examination - Day 0
Secondary Presence of sub-pleural consolidations Subpleural hypoechoic area with ragged margins (absence or presence) During lung ultrasound examination - Day 0
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