NCT03092557

Brief Summary

This study is designed to assess the feasibility of the measurement of local pleural strain at 4 different anatomical sites. The secondary objectives of the study are:

  • To assess intra- and inter-observer variability in the measurement of local pleural strain
  • To identify the strain parameters demonstrating the most clinically relevant and the most significant correlation with a change in tidal volume Hypothesis: The analysis of lung ultrasonographic sequences using speckle-tracking allows the determination of local pleural strain in 4 predetermined pulmonary areas.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 12, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

March 12, 2017

Last Update Submit

October 26, 2017

Conditions

Ventilator-Induced Lung InjuryMechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the measurement of local pleural strain using ultrasonography

    Proportion of successfully analyzed lung ultrasonographic clips

    At the end of study on Day 1

Secondary Outcomes (7)

  • Intra-observer variability

    At the end of study on Day 1

  • Inter-observer variability

    At the end of study on Day 1

  • Maximal axial deformation

    At the end of study on Day 1

  • Maximal lateral deformation

    At the end of study on Day 1

  • Mean magnitude of shear deformation

    At the end of study on Day 1

  • +2 more secondary outcomes

Study Arms (1)

Determination of local pleural strain

EXPERIMENTAL

Patients will receive four different tidal volumes in random order (6 mL/kg, 8 mL/kg, 10 mL/kg, 12 mL/kg).

Other: Determination of local pleural strain

Interventions

Determination of local pleural strainOTHER

For each tidal volume, the local pleural strain will be determined over three consecutive respiratory cycles at four predetermined sites using lung ultrasonography.

Determination of local pleural strain

Eligibility Criteria

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

You may qualify if:

  • Patients with presumed healthy lungs undergoing elective surgery under general anesthesia requiring neuromuscular blocking agents and orotracheal intubation

You may not qualify if:

  • Previous thoracic procedure (chest tube, thoracotomy, thoracoscopy)
  • Pre-existing pulmonary disease (asthma, chronic obstructive pulmonary disease, lung fibrosis)
  • Active or previous history of smoking
  • Need for supplemental oxygen
  • Abnormal pulmonary function tests (when available)
  • Obesity (Body Mass Index superior to 30 kg/m2)
  • Functional capacity inferior to 4 metabolic equivalent of task (METs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

Related Publications (1)

  • Girard M, Roy Cardinal MH, Chasse M, Garneau S, Cavayas YA, Cloutier G, Denault AY. Regional pleural strain measurements during mechanical ventilation using ultrasound elastography: A randomized, crossover, proof of concept physiologic study. Front Med (Lausanne). 2022 Sep 15;9:935482. doi: 10.3389/fmed.2022.935482. eCollection 2022.

    PMID: 36186794DERIVED

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective, interventional, cohort study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2017

First Posted

March 28, 2017

Study Start

July 24, 2017

Primary Completion

October 26, 2017

Study Completion

October 26, 2017

Last Updated

October 30, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)