NCT03405779

Brief Summary

The primary objective of the study is to create a small dataset of regional pulmonary strain values in patients suffering from pulmonary diseases under mechanical ventilation in an intensive care setting. Hypothesis: The analysis of lung ultrasonographic sequences using speckle-tracking allows the determination of local pleural strain in 4 predetermined pulmonary areas in mechanically ventilated patients suffering from pulmonary diseases.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 12, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

7.8 years

First QC Date

January 15, 2018

Last Update Submit

September 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average absolute lateral deformation

    Change in percentage from baseline expiratory value

    At the end of study on Day 1

Secondary Outcomes (6)

  • Cumulated range of absolute lateral deformation

    At the end of study on Day 1

  • Average absolute axial deformation

    At the end of study on Day 1

  • Cumulated range of absolute axial deformation

    At the end of study on Day 1

  • Average von mises

    At the end of study on Day 1

  • Average absolute lateral shear

    At the end of study on Day 1

  • +1 more secondary outcomes

Interventions

Mechanically ventilated patients suffering from pulmonary diseases will undergo a lung ultrasonography during their stay in the intensive care unit (ICU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Intensive care patients under mechanical ventilation suffering from a pulmonary disease.

You may qualify if:

  • Adult intensive care patients under mechanical ventilation suffering from a pulmonary disease with a static lung compliance of less than 40 mL/cm H2O.

You may not qualify if:

  • Obesity (Body Mass Index superior to 30 kg/m2)
  • Previous thoracic procedure (chest tube, thoracotomy, thoracoscopy)
  • Intra-abdominal pressure inferior to 15 mm Hg (if available)
  • Previous participation to the study

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

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Martin Girard, MD,FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 23, 2018

Study Start

March 12, 2018

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations