Efficacy and Physiology of Nasal High Flow Therapy

Institut für Pneumologie Hagen Ambrock eV

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Long term Oxygen Therapy (LOT); Device: NHF therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02083120

AIRVOhome

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

nasal High Flow and Oxygen

Experimental group

Description:

overnight nasal High Flow (NHF) therapy+ individually titrated supplemental oxygen (2-6 L/min),total 35 L/min, 4 weeks at home

Treatment:

Device: NHF therapy

Other: Long term Oxygen Therapy (LOT)

Long term Oxygen Therapy (LOT)

Active Comparator group

Description:

individually titrated supplemental oxygen (2-6 L/min), 4 weeks at home

Treatment:

Other: Long term Oxygen Therapy (LOT)