Screening Expiratory Flow Limitation by Flow-time Curve

NCT03215316 | Completed

• 1 other identifier: 17-098
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS, Human

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (1)

• Percentage of intrinsic PEEP caused by the EFL.

  2 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 12, 2017
• Study Start: September 1, 2017
• Primary Completion: August 12, 2024
• Study Completion: August 12, 2024
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

CA (1)