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Role of Lung Ultrasound and Pulsed-wave Doppler in Lung Consolidations in Mechanically Ventilated Patients

Primary Purpose

Atelectasis, Pneumonia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lung ultrasound and Doppler (Day 0)
Lung ultrasound and Doppler (Day 0 and Day 3 to 5)
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atelectasis focused on measuring Atelectasis, Pneumonia, Lung ultrasound, Doppler

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Known pulmonary artery hypertension
  • Known right ventricular failure
  • Antibiotics initiated more than 12 hours but less than 72 hours before inclusion or changes in the antibiotic regimen in the last 72 hours.

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Lung ultrasound and Doppler, pneumonia

Lung ultrasound and Doppler, atelectasis

Arm Description

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 and on Day 3 to 5. A bronchoalveolar lavage will also be performed on 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 only.

Outcomes

Primary Outcome Measures

RAcT in lung consolidations
Regional acceleration time measured by lung ultrasound and pulsed-wave Doppler

Secondary Outcome Measures

Temporal evolution of the RAcT
Change in the RAcT between day 0 and day 3 to 5 lung ultrasound exams
Presence of visible blood vessels on colour Doppler in lung consolidations
Graded semi-quantitatively (absence, single, multiple branching)
Presence of dynamic air bronchograms in lung consolidations
To-and-fro respiratory movement of punctiform or linear hyperechoic artifacts (absence or presence)
Presence of sub-pleural consolidations
Subpleural hypoechoic area with ragged margins (absence or presence)

Full Information

First Posted
March 27, 2014
Last Updated
December 13, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT02100449
Brief Title
Role of Lung Ultrasound and Pulsed-wave Doppler in Lung Consolidations in Mechanically Ventilated Patients
Official Title
Role of Lung Ultrasound Imaging and Pulsed-wave Doppler in the Assessment of Lung Consolidations in Mechanically Ventilated Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre de Recherche du Centre Hospitalier de l'Université de Montréal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Pneumonia
Keywords
Atelectasis, Pneumonia, Lung ultrasound, Doppler

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lung ultrasound and Doppler, pneumonia
Arm Type
Other
Arm Description
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 and on Day 3 to 5. A bronchoalveolar lavage will also be performed on Day 0.
Arm Title
Lung ultrasound and Doppler, atelectasis
Arm Type
Other
Arm Description
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 only.
Intervention Type
Other
Intervention Name(s)
Lung ultrasound and Doppler (Day 0)
Intervention Description
In patients presenting a consolidation of suspected atelectatic nature, a lung ultrasound examination using pulsed-wave Doppler will be performed on Day 0 only.
Intervention Type
Other
Intervention Name(s)
Lung ultrasound and Doppler (Day 0 and Day 3 to 5)
Intervention Description
In patients presenting a consolidation of suspected infectious nature, a lung ultrasound examination using pulsed-wave Doppler will be performed on Day 0 and on Day 3 to 5. A bronchoalveolar lavage will also be performed on Day 0.
Primary Outcome Measure Information:
Title
RAcT in lung consolidations
Description
Regional acceleration time measured by lung ultrasound and pulsed-wave Doppler
Time Frame
During lung ultrasound examination - Day 0
Secondary Outcome Measure Information:
Title
Temporal evolution of the RAcT
Description
Change in the RAcT between day 0 and day 3 to 5 lung ultrasound exams
Time Frame
During lung ultrasound examination - On day 0 and on day 3 to 5 (for patients in the pneumonia group only)
Title
Presence of visible blood vessels on colour Doppler in lung consolidations
Description
Graded semi-quantitatively (absence, single, multiple branching)
Time Frame
During lung ultrasound examination - Day 0
Title
Presence of dynamic air bronchograms in lung consolidations
Description
To-and-fro respiratory movement of punctiform or linear hyperechoic artifacts (absence or presence)
Time Frame
During lung ultrasound examination - Day 0
Title
Presence of sub-pleural consolidations
Description
Subpleural hypoechoic area with ragged margins (absence or presence)
Time Frame
During lung ultrasound examination - Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Known pulmonary artery hypertension Known right ventricular failure Antibiotics initiated more than 12 hours but less than 72 hours before inclusion or changes in the antibiotic regimen in the last 72 hours.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Girard, MD, FRCPC
Phone
514-890-8000
Ext
12131
Email
martin.girard@umontreal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Girard, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Girard, MD, FRCPC
Phone
514-890-8000
Ext
12131
Email
martin.girard@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Pierre Aslanian, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Christophe Kolan, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
André Denault, MD, FRCPC
First Name & Middle Initial & Last Name & Degree
Carl Chartrand-Lefebvre, MD, FRCPC

12. IPD Sharing Statement

Learn more about this trial

Role of Lung Ultrasound and Pulsed-wave Doppler in Lung Consolidations in Mechanically Ventilated Patients

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