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

NCT01596023 | Completed

• 1 other identifier: CP-00-0033
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Lung Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

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

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

  10 min

Secondary Outcomes (1)

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

  10 Min

Study Arms (1)

NIOV Ventilator

EXPERIMENTAL

Breathe NIOV Ventilator under various volume augmentation settings

Device: Breathe NIOV Ventilator

Interventions

Breathe NIOV Ventilator DEVICE

Portable, non invasive open ventilation system

NIOV Ventilator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Breathe Technologies, Inc.: lead
• Tufts Medical Center: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicholas Hill, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 10, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 15, 2014

Record last verified: 2014-01

Locations

US (1)