Screening Expiratory Flow Limitation by Flow-time Curve

NCT ID: NCT03215316

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2024-08-12

Brief Summary

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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.

Detailed Description

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Conditions

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ARDS, Human

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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17-098

Identifier Type: -

Identifier Source: org_study_id

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