Clinical Trials Logo
  1. Home
  2. ARDS, Human
  3. NCT03215316
  4. Details
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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06444750 - Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers
Not yet recruiting NCT05306392 - Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation N/A
Completed NCT04274296 - Advisory Lead ARDS Respirator Management
Terminated NCT04954014 - Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients Phase 2
Completed NCT04719182 - Practice of Adjunctive Treatments in Intensive Care Unit Patients With COVID-19
Recruiting NCT04115514 - Treatment of ARDS With Instilled T3 Phase 2
Not yet recruiting NCT05061212 - The Mechanism of Extracellular Vesicles Containing Mitochondrial DNA in ARDS Lung Injury Caused by Extrapulmonary Sepsis
Completed NCT05693051 - Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO
Not yet recruiting NCT04556864 - Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to COVID-19
Recruiting NCT04174014 - Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography N/A
Enrolling by invitation NCT06164639 - Potential Biomarkers for Reflux Aspiration-induced Lung Injury.
Terminated NCT05384379 - Efficacy and Safety Evaluation of BZ371B in ARDS Patients Early Phase 1
Completed NCT04375735 - London's Exogenous Surfactant Study for COVID19 Phase 1/Phase 2
Completed NCT06224010 - Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS
Not yet recruiting NCT04530188 - Effects of Sevoflurane on Extravascular Lung Water and Pulmonary Vascular Permeability in Patients With ARDS Phase 3
Completed NCT03405038 - Prone Position Impact in ARDS Patients on the Incidence of Central Venous Catheter Colonization
Recruiting NCT05148026 - Regional Citrate Anticoagulation for RRT During V-V ECMO N/A
Recruiting NCT04390360 - Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction N/A
Completed NCT06197256 - Cardiac Dysfunction in Critically Ill Covid-19 Patients
Completed NCT04008225 - Study of the Effects of Bronchoalveolar Lavage Liquid in the ARDS on the Functioning of the Neutrophil Polynuclear System