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OpenTrials
Completed

NCT Number: NCT03215316

Screening Expiratory Flow Limitation by Flow-time Curve

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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Key information

Conditions

ARDS, Human Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Acronym: FLOWLY

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2017
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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