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NCT03215316 Clinical Trial

Screening Expiratory Flow Limitation by Flow-time Curve

ARDS, Human Clinical Trial

— FLOWLY  

Official title:
Screening Expiratory Flow Limitation by Flow-time Curve

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03215316
Other study ID # 17-098
Secondary ID
Status Recruiting
Phase N/A
First received July 11, 2017
Last updated September 11, 2017
Start date September 1, 2017
Est. completion date September 2019

Study information
Verified date September 2017
Source St. Michael's Hospital, Toronto
Contact Laurent Brochard
Phone 416-864-5686
Email brochardl@smh.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Outcome (Presence / absence of EFL) will be determined by off-line analysis of recorded flow-volume loops during PEEP reduction. 2 years
Secondary Percentage of intrinsic PEEP caused by the EFL. 2 years
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