The Efficacy of the AIRVO Warm Humidifier as an Add on to Oxygen Therapy

NCT03081650 | Unknown

• 1 other identifier: 16-454
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• The change in number of hospitalizations warm humidification oxygen therapy and dry oxygen therapy.

  The change in number of hospitalizations compared to baseline data at 12 months.

  baseline, 12 months

• Change in the number of courses of antibiotic therapy compared to baseline data at 12 months

  baseline, 12 months

• Change in the number of courses of corticosteroid therapy compared to baseline data at 12 months.

  baseline, 12 months

• Change in the number of COPD medication therapy changes compared to baseline at 12 months.

  baseline, 12 months

Secondary Outcomes (3)

• Change in Spirometry measured pulmonary function between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.

  baseline, 12 months

• The change in distance walked during a 6 minute walk test between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.

  baseline, 12 months

• The change in the quality of life scores as measured by the Ferrans and Powers quality of life Index Pulmonary version III between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.

  baseline, 12 months

Study Arms (1)

Prospective Open label

EXPERIMENTAL

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

Device: Airvo Humidifier

Interventions

Airvo Humidifier DEVICE

Prospective Open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lutheran Hospital, Indiana: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Lutheran hospital

Fort Wayne, Indiana, 46804, United States

RECRUITING

Related Publications (10)

• Ringbaek TJ, Viskum K, Lange P. Does long-term oxygen therapy reduce hospitalisation in hypoxaemic chronic obstructive pulmonary disease? Eur Respir J. 2002 Jul;20(1):38-42. doi: 10.1183/09031936.02.00284202.

  PMID: 12166578 BACKGROUND

• Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.

  PMID: 6776858 BACKGROUND

• Golar SD, Sutherland LL, Ford GT. Multipatient use of prefilled disposable oxygen humidifiers for up to 30 days: patient safety and cost analysis. Respir Care. 1993 Apr;38(4):343-7.

  PMID: 10145893 BACKGROUND

• Yamashita K, Nishiyama T, Yokoyama T, Abe H, Manabe M. A comparison of the rate of bacterial contamination for prefilled disposable and reusable oxygen humidifiers. J Crit Care. 2005 Jun;20(2):172-5; discussion 175. doi: 10.1016/j.jcrc.2005.01.002.

  PMID: 16139158 BACKGROUND

• Loew DA, Klein SR, Chalon J. Volume-controlled relative humidity using a constant-temperature water vaporizer. Anesthesiology. 1972 Feb;36(2):181-4. doi: 10.1097/00000542-197202000-00024. No abstract available.

  PMID: 5059111 BACKGROUND

• Salah B, Dinh Xuan AT, Fouilladieu JL, Lockhart A, Regnard J. Nasal mucociliary transport in healthy subjects is slower when breathing dry air. Eur Respir J. 1988 Oct;1(9):852-5.

  PMID: 3229484 BACKGROUND

• Miyamoto K, Nishimura M. Nasal dryness discomfort in individuals receiving dry oxygen via nasal cannula. Respir Care. 2008 Apr;53(4):503-4. No abstract available.

  PMID: 18397537 BACKGROUND

• Franchini ML, Athanazio R, Amato-Lourenco LF, Carreirao-Neto W, Saldiva PH, Lorenzi-Filho G, Rubin BK, Nakagawa NK. Oxygen With Cold Bubble Humidification Is No Better Than Dry Oxygen in Preventing Mucus Dehydration, Decreased Mucociliary Clearance, and Decline in Pulmonary Function. Chest. 2016 Aug;150(2):407-14. doi: 10.1016/j.chest.2016.03.035. Epub 2016 Apr 2.

  PMID: 27048871 BACKGROUND

• Rea H, McAuley S, Jayaram L, Garrett J, Hockey H, Storey L, O'Donnell G, Haru L, Payton M, O'Donnell K. The clinical utility of long-term humidification therapy in chronic airway disease. Respir Med. 2010 Apr;104(4):525-33. doi: 10.1016/j.rmed.2009.12.016. Epub 2010 Feb 9.

  PMID: 20144858 BACKGROUND

• Wier LM, Elixhauser A, Pfuntner A, Au DH. Overview of Hospitalizations among Patients with COPD, 2008. 2011 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #106. Available from http://www.ncbi.nlm.nih.gov/books/NBK53969/

  PMID: 21510031 BACKGROUND

Related Links

• What is COPD? National Heart Lung and Blood Institute: Diseases and Conditions Index. June 2010.

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

• Eustace Fernandes, MD

  Lutheran hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gordon Bokhart, Pharm D

CONTACT

260-435-7718; gbokhart@lhn.net

Lisa Burris, RRT, CFPT

CONTACT

260-435-7890; lburris@lhn.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will be conducted as an open label, non-randomized trial.

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 16, 2017
• Study Start: August 16, 2016
• Primary Completion: August 16, 2017
• Study Completion: December 1, 2017
• Last Updated: March 16, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)