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CompletedNCT03215316FLOWLYUpdated May 20, 2025

Screening Expiratory Flow Limitation by Flow-time Curve

An observational study in ARDS, Human, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-05-20.

Sponsored by Unity Health Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years to 99 Years
Sex
All
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Study summary

Expiratory flow limitation (EFL) is defined as a dynamic condition that expiratory flow cannot be further increased with higher expiratory driving pressure. Under mechanical ventilation, it can cause intrinsic positive end-expiratory pressure (PEEP) and dynamic hyperinflation, and be associated with worse clinical outcome. The detection of EFL however needs special maneuvers and offline analysis of flow-volume curves, which are infeasible in routine practice and cannot be used during real-time monitoring. The investigators propose a new and simple approach using flow derived parameters to detect EFL in real time without needing any intervention.

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Conditions studied

  • ARDS, Human
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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 45 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Intubated patients in the intensive care unit (ICU) receiving mechanical ventilation.

Inclusion criteria

  1. Age ≥18 years, intubated or tracheostomized
  2. Receiving invasive mechanical ventilation in assist/control mode with PEEP ≥ 5 cmH2O
  3. Receiving continuous intravenous sedation
  4. Displaying a monotonous regular breathing pattern with no obvious asynchrony

Exclusion criteria

Exclusion Criteria:

  1. Severe hypoxemia in baseline clinical ventilator settings (SpO2 \< 90%)
  2. Hemodynamic instability (mABP \<60 mmHg, systolic arterial pressure >180 mmHg, heart rate \<40/min or >150/min)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Outcome (Presence / absence of EFL) will be determined by off-line analysis of recorded flow-volume loops during PEEP reduction.

    Time frame: 2 years

Secondary outcomes

  1. Percentage of intrinsic PEEP caused by the EFL.

    Time frame: 2 years

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Study locations

1 site
  • St. Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03215316
Lead sponsor
Unity Health Toronto
Responsible party
Sponsor
First posted
Jul 12, 2017
Start date
Sep 1, 2017
Primary completion
Aug 12, 2024
Completion
Aug 12, 2024
Last update
May 20, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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