Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease

Interstitial Lung Disease Clinical Trial

Official title:

Evaluation of a Lightweight Nasal Interface and Ventilator for Use by Patients With Respiratory Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02278107
• Other study ID #: JM-001-2014
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 23, 2014
• Last updated: February 26, 2016
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: New Aera, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A preliminary study to evaluate a new nasal interface and portable ventilator system in comparison to standard oxygen therapy in patients with severe chronic lung disease.

Description:

An open-label, randomized, controlled, crossover study in patients with severe chronic lung disease to evaluate exercise tolerance compared to standard nasal cannula oxygen therapy.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult male or female (> 18 years of age) with a diagnosis of severe-to-very severe chronic lung disease

• Participates in a qualified pulmonary rehabilitation program

• Requires constant flow oxygen of = 2 LPM (liters per minute) during exercise

• Able and willing to sign the informed consent

• Ability to be fitted with the test nasal mask and to use the test ventilator system

Exclusion Criteria:

• Requires > 5LPM of constant flow to maintain SpO2> 90% during exercise

• Reports having serious epistaxis within the last 14 days prior to enrollment

• Currently enrolled in another clinical study or has participated within 30 days of enrollment

• Has any condition or abnormality that in the opinion of the Investigators may compromise the participant's safety or the quality of the study data

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Device:
• Tidal Assist Ventilator System
Tidal volume augmentation with supplemental oxygen. Source gas options: cylinder, concentrator, wall.
• Nasal Cannula Oxygen
Standard oxygen therapy delivered by nasal cannula at 2-5 lpm based on patient requirements. Source gas options: cylinder, concentrator, wall.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New Aera, Inc

References & Publications (1)

Porszasz J, Cao R, Morishige R, van Eykern LA, Stenzler A, Casaburi R. Physiologic effects of an ambulatory ventilation system in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Aug 1;188(3):334-42. doi: 10.1164/rccm.201210-1773OC. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Endurance Time to Maximum Tolerance	Endurance measured on cycle ergometer at predetermined constant work rate. Subjects will exercise to their limit of tolerability (max effort).	Maximum exercise endurance in minutes, for both treatment arms. Two 4-hr study visits, 1 week apart. Endurance endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.	No
Secondary	Borg 10 Dyspnea Score, Subject reported	10 point Analog scale	Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.	No
Secondary	Arterial Oxygen Saturation via Pulse Oximeter (SpO2)	SpO2 measured via forehead and finger pulse oximeters	Recorded 1-2 min before and every 1 minute during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.	No
Secondary	Leg Fatigue, Subject Reported	10 point Analog scale	Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.	No
Secondary	Heart Rate	Heart rate recorded by pulse oximeters	Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.	No
Secondary	Respiratory Rate	Respiratory rate recorded by observer	Recorded 1-2 min before and every 1 min during exercise. Evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.	No
Secondary	Adverse Events	Monitoring for observed or reported adverse reactions	Two 4-hr study visits, sheduled 1 week apart. Subjects will be monitored for AEs continuously throughuout the study visit. AEs will be monitored and recored during both study visits.	Yes