The Effect of Oxygen Therapy With Airvo High-flow Heated Humidification

NCT02731872 | Completed DMC

• 1 other identifier: N-20110057
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of our study is to establish whether domiciliary use of the Airvo warm passover humidifier can reduce the number of exacerbations in patients with respiratory insufficiency. Participants must have a diagnosis of chronic obstructive pulmonary disease (COPD) and be in long term oxygen therapy (LTOT). The following questions will be investigated: Do outpatients receiving long term oxygen therapy benefit if this is delivered through an Airvo humidification system. The proposed benefits under investigation are:

1. 1.a reduction in the number of exacerbations and thus hospital admissions?
2. 2.an increase in quality of life (QOL)?
3. 3.an improved lung function and thus increased physical activity?

Conditions

COPD

Keywords

COPD; oxygen treatment; quality of life

Outcome Measures

Primary Outcomes (1)

• Reduction in the number of exacerbations and thus hospital admissions, based on data on hospital admissions.

  Outcomes relating to exacerbations will be recorded according to GOLD COPD guidelines: An exacerbation of COPD is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD (3). At inclusion of the patient, the number of exacerbations (deterioration) in the last year, based on data on the need for antibiotics and/or prednisolone (corticosteroid), and hospital admissions will be registered. Data will be recorded via extracts from AS400 and the prescription database. To ensure data validity concerning redeemed prescriptions, patients will be asked about the number of self-treatment plans. At project completion, the same metrics are recorded for the entire period.

  one year

Secondary Outcomes (3)

• increase in quality of life, measured by St George's Respiratory Questionnaire (SGRQ),

  six month and one year

• improved lung function, using Spida 5 equipment.

  one year

• Improved physical ability, based on six-minute walk test.

  one year

Study Arms (2)

High Flow humidification system

EXPERIMENTAL

In addition to their usual oxygen apparatuses, the treatment group will have an Airvo humidifier system installed in the home. The supplied oxygen flow will be entrained along with room air through the Airvo humidification system. this combined respiratory gas will then be warmed and humidified and delivered to the patient via a nasal cannula. The total respiratory gas flow rate will be between 20-25 l/min, depending on participant´s preference. Then the oxygen fraction is adjusted until the subjects target oxygen saturation levels are achieved.

Device: Airvo humidifier

Standard oxygen therapy

NO INTERVENTION

The control group will continue receiving the standard oxygen therapy prescribed by the department

Interventions

Airvo humidifier DEVICE

The Airvo humidifier has adjustable flow settings for delivery of fully saturated breathing gases at 37 °C, 100% humidity. Flow rates are adjustable between 15 and 45 l/min. Ambient air is drawn in by a low-capacity motor. When coupled to a medical oxygen supply, the regulation of delivered oxygen concentration is ensured.

High Flow humidification system

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have severe/very severe COPD diagnosis
• have had chronic respiratory insufficiency for at least 3 months and be in steady oxygen therapy (LTOT) with a minimal supplement of 1 litre of oxygen per minute for at least 16 hours per day
• understand and accept oral and written information in Danish
• be capable of handling the Airvo warm humidifier after instruction.

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 project period.

Sponsors & Collaborators

• Birgitte Schantz Laursen: lead
• Fisher and Paykel Healthcare: collaborator
• AGA The Linde Group: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, Nothern Jutland, 9000, Denmark

Location

Related Publications (1)

• Dansk Selskab for Almen Medicin. Klinisk vejledning: KOL i almen praksis - diagnostik, behandling, opfølgning, rehabilitering. 2008. Sundhedsstyrelsen: KOL - kronisk obstruktiv lungesygdom. Anbefalinger for tidlig opsporing, opfølgning, behandling og rehabilitering. 2007. Ringbæk, T, Taudorf, E, Overgaard, A, Sorknæs, A og Fabricius, P. Protokol for Iltbehandling i hjemmet. Dansk Lungemedicinsk Selskabs rekommandationer. 2006. Kampelmacher, MJ, Van Kesteren, RG, Alsbach, GPJ et al. Characteristics and complaints of patients prescribed long-term oxygen therapy in The Netherlands. Respiratory Medicine, 92, 70-75, 1998 Medicinsk Kompendium. Kap. 37 Lungesygdomme Cambell, EJ, Baker, MD, Crites-Silver, P. Subjective effects of humidification of oxygen for delivery by nasal cannula. A prospective study. Chest, 93, 289-293, 1988. Gorecka, D, Gorzelak, K, Sliwinski, P, Tobiasz, M, Zielinski, J. Effect of long term oxygen therapy on survival in patients with chronic obstructive pulmonary disease with moderate hypoxaemia. Thorax, 52, 674-679, 1997. Rea, H, McAuley, S, Jayaram, L, Garrett, J, Hockey, H et al. The clinical utility of long-term humidification therapy in chronic airway disease. Respiratory Medicine, 104, 525-533, 2010. Fisher & Paykel Healthcare. Airvo. Hospital Use Operating Manual. Siggaard-Andersen, O, Gøthgen, IH, Wimberley, PD, Fogh-Andersen, N. The oxygen status of the arterial blood revised: relevant oxygen parameters for monitoring the arterial oxygen availability. Scand J Clinical Lab Invest, 50, suppl. 203, 17-28, 1990.

  BACKGROUND

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

• Ulla M Weinreich, MD

  Department for Pulmonary Medicine, Aalborg University Hospital, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: April 8, 2016
• Study Start: January 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)