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Screening Expiratory Flow Limitation by Flow-time Curve

Screening Expiratory Flow Limitation by Flow-time Curve

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03215316
Acronym
FLOWLY
Enrollment
45
Registered
2017-07-12
Start date
2017-09-01
Completion date
2024-08-12
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS, Human

Brief 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.

Interventions

None listed

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

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)

Design outcomes

Primary

MeasureTime frame
Outcome (Presence / absence of EFL) will be determined by off-line analysis of recorded flow-volume loops during PEEP reduction.2 years

Secondary

MeasureTime frame
Percentage of intrinsic PEEP caused by the EFL.2 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026