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NCT Number: NCT01596023

Evaluation of Breathe NIOV System on Work of Breathing in Chronic Obstructive Lung Disease Patients

The Breathe Ventilator is a lightweight, wearable ventilator that has received U.S. FDA clearance for use in patients with respiratory difficulty. The investigators believe that the Breathe NIOV system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. This will be a study in 14 patients with severe-to-very severe chronic obstructive lung disease (COPD) to assess their work of breathing while using the NIOV system as measured by esophageal and stomach pressures.

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Key information

Conditions

Chronic Obstructive Lung 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

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is >18 years of age at time of consent.
  • Subject has diagnosis of severe COPD (GOLD stage III or IV) as demonstrated by a FEV1 < 50% predicted and FEV1/FVC ratio < 70% predicted.
  • Subject has increased inspiratory muscle work of breathing as evidenced by palpable sternocleidomastoid muscle contraction during inspiration

Exclusion criteria

  • Subject has acute exacerbation of COPD - within 1 week of acute hospitalization
  • Subject has respiratory rate at rest > 28/min
  • Subject requires > 5 L/min nasal O2/min to maintain O2sat > 90%
  • Subject has severe dyspnea at rest
  • Subject has swallowing disorders or chronic aspiration, prior esophageal surgery, or any other condition that would place the subject at risk during balloon placement.
  • Subject has history of pneumothorax secondary to lung bullae.
  • Subject is too cognitively impaired to give subjective ratings for visual analog scale
  • Subject has sensitivity or an allergy to lidocaine
  • Subject has known history of oxygen intolerance.

Treatment and study plan

Breathe NIOV Ventilator

Device

Portable, non invasive open ventilation system

Primary outcomes

  1. Pressure time product of the diaphragm (PTPdi) during use of the Breathe Ventilation System

    Time frame: 10 min

    Calculated using the area of the transdiaphragmatic pressure for the duration of inspiration

Secondary outcomes

  1. Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min

    Time frame: 10 Min

    Changes in PTP of the esophagus (PTPes), PTP per minute (PTPdi/min and PTPes/min)

Sponsors and collaborators

Lead sponsor

Breathe Technologies, Inc.

Industry

Collaborators

  • Tufts Medical Center

Registry information

Official study title

Evaluation of Effect of Breathe Ventilation System on Work of Breathing in COPD Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 10, 2012
Registry last updated
Jan 15, 2014

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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