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Completed

NCT Number: NCT01151618

Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation

To validate the capability of the Respironics Synchrony ventilator to properly detect Expiratory Flow Limitation (EFL) as compared to the gold standard method of detecting EFL via the Mead and Wittenberger technique.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Aintree

Liverpool, L97AL, United Kingdom

About this study

Positive end expiratory pressure (PEEP) is used in COPD patients to counteract the intrinsic PEEP (PEEPi), which represents the end expiratory recoil pressure of the total respiratory system due to the presence of dynamic hyperinflation (DH).

DH commonly occurs in COPD, where the presence of expiratory flow-limitation (EFL) requires the patient to breath at higher lung volumes to produce the necessary after appropriate leak correction, showed a sensitivity and specificity in detecting EFL expiratory flow. To be effective, the PEEP level applied to the patient should be equal to PEEPi.

The continuous monitoring of EFL could be a useful tool to select the minimum PEEP level required to abolish it.

EFL can be detected using the forced oscillation technique (FOT) by an index which quantifies, for each breath, the within-breath variations of respiratory reactance (delta Xrs) at 5Hz.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age < 80 years
  • Moderate - Severe COPD diagnosed by spirometry (according to the GOLD criteria - Global Initiative for Chronic Obstructive Lung Disease criteria)
  • Free from any exacerbation in the 6 weeks preceding the study

Exclusion criteria

  • Any co-existing cardio-pulmonary conditions which may result in a picture of ventilatory failure such as congestive cardiac failure, chest wall or neuromuscular disease, bronchopneumonia, pulmonary fibrosis, bronchiectasis, cystic fibrosis or obesity-hypoventilation syndrome
  • Clinically unstable; exacerbation within the preceding 6 weeks
  • The presence of pulmonary or extra-pulmonary neoplasia that is still active
  • The presence of a bleeding diathesis
  • Unstable coronary artery disease
  • Presence of tuberculosis, current infection or potentially infectious pathogen
  • Inability to provide informed consent to the study

Treatment and study plan

Respironics Synchrony ventilator (Non Invasive Ventilation)

Device

Non Invasive Ventilation using forced oscillation technique (FOT)

Primary outcomes

  1. Detection of Expiratory Flow Limitation

    Time frame: within 2 hours

    Expiratory flow limitation (EFL) is an increase in transpulmonary pressure (cmH2O) with no change expiratory flow (lpm).

    Expiratory Flow Limitation or absence thereof will be detected by using a measurement of changes in reactance (DeltaXrs - cmH2O*s/L) it will be compared to the the Mead and Whittenberger technique (via esophageal balloon measuring transpulmonary pressures).

    Two measurements will be obtained, DeltaXrs and Transpulmonary pressure. Comparisons of these measurements will be made to determine if the participant exhibits EFL.

  2. Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator

    Time frame: 2 hours

    Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.

  3. Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique

    Time frame: 2 hours

    Number of breaths are cumulative across all participants were found to be flow limited, not-flow limited or indeterminate as determined by the Mead and Wittenberger (M-W) technique of esophageal pressure. Each participant's individual breaths was imported into Matlab software program that displayed the flow vs transpleural pressure and breaths were individually analyzed according to the Mead Wittenberger technique.

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Official study title

Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation in Patients With Stable Chronic Pulmonary Disease (COPD)

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 28, 2010
Registry last updated
Mar 18, 2019

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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