NCT02100449

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

10.4 years

First QC Date

March 27, 2014

Last Update Submit

February 6, 2024

Conditions

Keywords

AtelectasisPneumoniaLung ultrasoundDoppler

Outcome Measures

Primary Outcomes (1)

  • RAcT in lung consolidations

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

    During lung ultrasound examination - Day 0

Secondary Outcomes (3)

  • Presence of visible blood vessels on colour Doppler in lung consolidations

    During lung ultrasound examination - Day 0

  • Presence of dynamic air bronchograms in lung consolidations

    During lung ultrasound examination - Day 0

  • Presence of sub-pleural consolidations

    During lung ultrasound examination - Day 0

Study Arms (2)

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.

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.

Other: Lung ultrasound and Doppler (Day 0)

Interventions

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, atelectasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Under mechanical ventilation and presenting one or more consolidations on chest radiography or CT scan

You may not qualify if:

  • Participation to another study
  • Poor echogenicity (morbid obesity, multiple thoracic dressings)
  • Contra-indications to superior limbs or torso mobilization
  • Contra-indications to bronchoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

MeSH Terms

Conditions

Pulmonary AtelectasisPneumonia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiratory Tract InfectionsInfections

Study Officials

  • Martin Girard, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Girard, MD, FRCPC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

June 1, 2014

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations