Clinical trial NCT02083120: Efficacy and Physiology of Nasal High Flow Therapy
Official title: Efficacy and Physiology of Nasal High Flow Therapy (AIRVO2™, Fisher&Paykel) in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Hypercapnic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: high flow
COPD
AIRVO
Lead sponsor: Institut für Pneumologie Hagen Ambrock eV
Sponsor class: INDUSTRY
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2014-03-11
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The effects of a nasal high-flow (NHF) therapy in patients with chronic obstructive hypercapnic respiratory failure are still not sufficiently known yet.

The aim of this study is a step-by-step generation of physiological data about gas exchange and respiration under high flow therapy using a nasal cannula with an AIRVO 2 device to provide NHF, leading to an analysis of the effects of high flow on PCO2 levels, exercise capacity, quality of life and gas exchange in a long term home treatment compared to a standard low flow long term oxygen therapy (LOT).

Hypothesis: NHF and LOT therapy show differences in measured mean overnight transcutaneous carbon dioxide partial pressure (PCO2) after four weeks of treatment.

Detailed description: Stage 1: Respiratory Physiology. Aim of this Stage is to investigate the effects of nasal High Flow (NHF) therapy in patients in progressed stages of COPD, by measuring physiologic parameters like tidal volume, breathing frequency and expiratory PCO2 concentration.

Stage 2: Efficacy of short term NHF. Aim of this Stage is to evaluate the efficacy of two flow rates (20 L/min and 35 L/min) regarding alveolar ventilation in overnight therapy. For this reason, patients will have two PSG sleep studies during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order.

Stage 3: Home Care monitoring. Aim of this Stage is to compare long term influences of NHF and LOT on PCO2 levels randomised crossover, 4 weeks each treatment.

Stage 4: Long Term Home Care monitoring . Aim of this stage is the long term follow up (12 month) of patients to examine the compliance of a sufficient NHF therapy. Patients will retain the NHF therapy if they are responders (PCO2 improvement in stage 3 of at least 2 mmHG with NHF versus LOT) and willing and able to use NHF and a patient log.

All patients will be monitored for the next 12 month. After 6 month there will be a control phone call.

Eligibility criteria: Inclusion Criteria:

* Age 40-80
* Male and female
* COPD patients with chronic respiratory insufficiency (pH \>7.35 and PCO2 \> 50mmHg)
* Stable respiratory situation

Exclusion Criteria:

* Decompensated heart, liver or kidney failure.
* Pregnancy or nursing period
* Participation in another clinical trial within the last 4 weeks
* Drug abuse
* Incapable of giving consent
* Known obstructive sleep apnea syndrome (OSA) (AHI\>10)
* noninvasive ventilation (NIV) therapy

Primary outcomes:
measure: mean overnight transcutaneous PCO2
timeFrame: baseline
measure: mean overnight transcutaneous PCO2
timeFrame: after 4 weeks
measure: mean overnight transcutaneous PCO2
timeFrame: after 12 month
Secondary outcomes:
measure: quality of life with Saint Georges Respiratory Questionnaire (SGRQ)
timeFrame: after 4 weeks, 8 weeks and 12 month
Other outcomes:
measure: sleep quality
timeFrame: baseline, after 4 weeks, after 8 weeks, after 12 month
Locations:
city: Hagen
country: Germany
facility: Helios Klinik Ambrock
state: NRW
Study officials:
affiliation: Helios Klinik Ambrock
name: Georg Nilius, MD
role: PRINCIPAL_INVESTIGATOR
References: