Recruiting

AIRVO

Sponsor:

Lutheran Hospital, Indiana

Code:

NCT03081650

Conditions

COPD

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Airvo Humidifier

Study Details

Brief summary:

The primary purpose of this study is to show whether at home usage of the AIRVO warm humidifier can potentially reduce the number of exacerbations in patients with significant respiratory insufficiency. Eligible participants of the study must have a diagnosis of chronic obstructive pulmonary disease (COPD) stage II-IV..

Conditions

COPD

Chronic Obstructive Pulmonary Disease

Study ID

NCT03081650

Start date

Aug 16, 2016

Status verified date

Feb, 2017

Completion date

Dec 1, 2017

Anticipated

Primary completion date

Aug 16, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Have stage II-IV COPD diagnosis Understand and accept oral and written information in English Be capable of handling the AIRVO warm humidifier after instruction >18years of age

Exclusion Criteria:

  • Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental illness)
  • Bronchiectasis without simultaneous COPD diagnosis
  • Treatment with BiPAP in the home
  • Affected level of consciousness
  • Smoking status change during study period
  • Inability to provided signed consent

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prospective Open label

All of the patients that will be Selected to participate in the study will be given an AIRVO humidifier by the study sponsor. Patients will be connected to and instructed in the use of the AIRVO. The total flow will be set at 20-25 L/min, exact flow rate will be dependent on the patient's preference. Optiflow oxygen catheter will be used to ensure against unpleasant sensation due to high flow and to avoid push back in the system.

When acceptable flow rated has been established, it is recorded in the patient's folder. The patients is then instructed to use the AIRVO for a minimum eight (8) hour period, preferably at night. Using the humidifier for a longer period of time is allowed. The total number of hours the humidifier was operational will be recorded at the end of the study

Interventions

Airvo Humidifier

Primary outcome measure

  • The change in number of hospitalizations warm humidification oxygen therapy and dry oxygen therapy. [ Time Frame: baseline, 12 months ]
  • Change in the number of courses of antibiotic therapy compared to baseline data at 12 months [ Time Frame: baseline, 12 months ]
  • Change in the number of courses of corticosteroid therapy compared to baseline data at 12 months. [ Time Frame: baseline, 12 months ]
  • Change in the number of COPD medication therapy changes compared to baseline at 12 months. [ Time Frame: baseline, 12 months ]

Central Contacts and Locations

Central contacts

Gordon Bokhart, Pharm D

260-435-7718gbokhart@lhn.net

Lisa Burris, RRT, CFPT

260-435-7890lburris@lhn.net

Locations

Lutheran hospital

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

Gordon Bokhart, Pharm D

260-435-7718gbokhart@lhn.net

Lisa Burris, RRT, CPFT

260-435-7890lburris@lhn.net

Principal Investigator:

Eustace Fernandes, MD

More Information

Sponsor

Lutheran Hospital, Indiana

Last update posted

Mar 16, 2017

Last verified

Feb, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lutheran Hospital, Indiana on 2017-03-16.