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Effect of Portable NIV on Operational Chest Wall Volumes in COPD

NCT03848819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-09-11

No results posted yet for this study

Summary

The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown to reduce activity-related shortness of breath in patients with COPD. The VitaBreath device delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods.

A previous study (REC: 17/NE/0085) showed that use of the VitaBreath device during the recovery periods interspersing successive exercise bouts enhances exercise tolerance and reduces breathlessness compared to pursed lip breathing in patients with COPD. This was attributed to faster recovery from exercise-induced dynamic hyperinflation, assessed by volitional inspiratory capacity manoeuvres using a spirometer. However, inspiratory capacity manoeuvres are effort dependent, thus limiting the number of repetitions the patient can perform during exercise. In addition, investigation of the direct effect of the application of the VitaBreath device on dynamic hyperinflation was not possible due to the need to employ a spirometer for assessing inspiratory capacity. Optoelectronic plethysmography (OEP) allows continuous non-invasive assessment of end-inspiratory and end-expiratory volumes of the thoracoabdominal wall and its compartments, thereby facilitating assessment of dynamic hyperinflation on a breath-by-breath basis without the necessity to breathe via a spirometer. Unfortunately, OEP technology was not available at the time of our previous study.

The investigators will use OEP to provide accurate breath-by-breath volume measurements during exercise and recovery to evaluate whether the VitaBreath device reduces total and compartmental thoracoabdominal wall volumes compared to the pursed lip breathing technique.

Furthermore, the investigators will investigate the effect of use of the VitaBreath device on respiratory muscle activation and respiratory muscle oxygenation using OEP technology in conjunction with electromyography (EMG) and near inferred spectroscopy (NIRS), respectively to appreciate how the application of the VitaBreath device impacts on the operation and energy demands of the respiratory muscles as compared to control pursed lip breathing.

The investigators hypothesised that the use of the VitaBreath device during the recovery periods interspersing successive exercise bouts will reduce the magnitude of dynamic hyperinflation in a greater extent compared to the pursed lip breathing technique.

Conditions

Interventions

DEVICE

VitaBreath device

The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown by our group to reduce activity-related shortness of breath in patients with COPD. It delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods. In our study patients will perform consecutive bouts of exercise alternated by two minute of recovery in order to allow the use of the VitaBreath device during the first minute of each recovery period.

Sponsors & Collaborators

  • North Tyneside General Hospital

    collaborator OTHER_GOV

  • Northumbria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2019-12-20
Completion
2020-02-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03848819 on ClinicalTrials.gov