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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT02100449
First received: March 27, 2014
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Atelectasis
Pneumonia
Other: Lung ultrasound and Doppler (Day 0)
Other: Lung ultrasound and Doppler (Day 0 and Day 3 to 5)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Role of Lung Ultrasound Imaging and Pulsed-wave Doppler in the Assessment of Lung Consolidations in Mechanically Ventilated Patients.

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • RAcT in lung consolidations [ Time Frame: During lung ultrasound examination - Day 0 ] [ Designated as safety issue: Yes ]
    Regional acceleration time measured by lung ultrasound and pulsed-wave Doppler


Secondary Outcome Measures:
  • Temporal evolution of the RAcT [ Time Frame: During lung ultrasound examination - On day 0 and on day 3 to 5 (for patients in the pneumonia group only) ] [ Designated as safety issue: Yes ]
  • Presence of visible blood vessels in lung consolidations [ Time Frame: During lung ultrasound examination - Day 0 ] [ Designated as safety issue: Yes ]
  • Presence of dynamic air bronchograms in lung consolidations [ Time Frame: During lung ultrasound examination - Day 0 ] [ Designated as safety issue: Yes ]
  • Presence of sub-pleural consolidations [ Time Frame: During lung ultrasound examination - Day 0 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 62
Study Start Date: June 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 and on Day 3 to 5. A bronchoalveolar lavage will also be performed on Day 0.
Other: Lung ultrasound and Doppler (Day 0 and Day 3 to 5)
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.
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 only.
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 only.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02100449

Contacts
Contact: Martin Girard, MD, FRCPC 514-890-8000 ext 26876 martin.girard@mail.mcgill.ca
Contact: Gabrielle Migner-Laurin, MD 514-890-8444 courrieludem@gmail.com

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM) Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Martin Girard, MD, FRCPC    514-890-8000 ext 26876    martin.girard@mail.mcgill.ca   
Contact: Gabrielle Migner-Laurin, MD    514-890-8444    courrieludem@gmail.com   
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         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Martin Girard, MD, FRCPC Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02100449     History of Changes
Other Study ID Numbers: 14.005
Study First Received: March 27, 2014
Last Updated: June 5, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Atelectasis
Pneumonia
Lung ultrasound
Doppler

Additional relevant MeSH terms:
Pulmonary Atelectasis
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 28, 2014