Evaluating Forced Oscillation Technique (FOT) in Abolishing Flow Limitation

NCT01151618 | Completed Results

• 1 other identifier: HRC-1018-FOTVal-SS
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Respironics Synchrony ventilator (Non Invasive Ventilation)

EXPERIMENTAL

Non Invasive Ventilation using forced oscillation technique (FOT)

Device: Respironics Synchrony ventilator (Non Invasive Ventilation)

Interventions

Respironics Synchrony ventilator (Non Invasive Ventilation) DEVICE

Non Invasive Ventilation using forced oscillation technique (FOT)

Respironics Synchrony ventilator (Non Invasive Ventilation)

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (1)

University Hospital Aintree

Liverpool, L97AL, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Bob Romano, Biomedical Engineer
• Organization: Philips Respironics

bob.romano@philips.com

724-387-7781

Study Officials

• Peter Calverley, Professor

  Aintree University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 28, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 18, 2019
• Results First Posted: March 18, 2019

Record last verified: 2019-03

Locations

GB (1)