Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151618
• Other study ID #: HRC-1018-FOTVal-SS
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: September 2010

Study information

• Verified date: March 2019
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria

1. Age < 80 years

2. Moderate - Severe COPD diagnosed by spirometry (according to the GOLD criteria - Global Initiative for Chronic Obstructive Lung Disease criteria)

3. Free from any exacerbation in the 6 weeks preceding the study

Exclusion Criteria

1. 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

2. Clinically unstable; exacerbation within the preceding 6 weeks

3. The presence of pulmonary or extra-pulmonary neoplasia that is still active

4. The presence of a bleeding diathesis

5. Unstable coronary artery disease

6. Presence of tuberculosis, current infection or potentially infectious pathogen

7. Inability to provide informed consent to the study

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Respironics Synchrony ventilator (Non Invasive Ventilation)
Non Invasive Ventilation using forced oscillation technique (FOT)

Locations

Country	Name	City	State
United Kingdom	University Hospital Aintree	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Expiratory Flow Limitation	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.	within 2 hours
Primary	Detection of Expiratory Flow Limitation by a Commercial Mechanical Ventilator	Number of participants found to have expiratory flow limitation as determined by a commercial mechanical ventilator.	2 hours
Primary	Detection of Expiratory Flow Limitation by Mead and Wittenberger (M-W) Technique	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.	2 hours