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

February 6, 2024 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
        • Sub-Investigator:
          • Pierre Aslanian, MD, FRCPC
        • Sub-Investigator:
          • Christophe Kolan, MD, FRCPC
        • Sub-Investigator:
          • André Denault, MD, FRCPC
        • Sub-Investigator:
          • Carl Chartrand-Lefebvre, MD, FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lung ultrasound and Doppler, pneumonia
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.
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.
Other: 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, atelectasis
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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RAcT in lung consolidations
Time Frame: During lung ultrasound examination - Day 0
Regional acceleration time measured by lung ultrasound and pulsed-wave Doppler
During lung ultrasound examination - Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of visible blood vessels on colour Doppler in lung consolidations
Time Frame: During lung ultrasound examination - Day 0
Graded semi-quantitatively (absence, single, multiple branching)
During lung ultrasound examination - Day 0
Presence of dynamic air bronchograms in lung consolidations
Time Frame: During lung ultrasound examination - Day 0
To-and-fro respiratory movement of punctiform or linear hyperechoic artifacts (absence or presence)
During lung ultrasound examination - Day 0
Presence of sub-pleural consolidations
Time Frame: During lung ultrasound examination - Day 0
Subpleural hypoechoic area with ragged margins (absence or presence)
During lung ultrasound examination - Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Investigators

  • Principal Investigator: Martin Girard, MD, FRCPC, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

March 31, 2014

First Posted (Estimated)

April 1, 2014

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14.005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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