Efficacy and Physiology of Nasal High Flow Therapy

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083120
• Other study ID #: AIRVOhome
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: November 1, 2018

Study information

• Verified date: February 2019
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• NHF therapy
AIRVO 2 device therapy is either a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. Flow rates up to 60 L/min are available to the user, depending on the patient interface and mode of operation.In this study, flow rates of 20 L/min and 35 L/min will be compared.

Other:
• Long term Oxygen Therapy (LOT)
Oxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%.

Locations

Country	Name	City	State
Germany	Helios Klinik Ambrock	Hagen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pneumologie Hagen Ambrock eV	Fisher and Paykel Healthcare

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sleep quality	sleep quality, measured by sleep efficiency, e.g. total sleep time vs sleep period time from PSG report.	baseline, after 4 weeks, after 8 weeks, after 12 month
Primary	mean overnight transcutaneous PCO2	In two baseline measurements the aim 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 polysomnographic sleep studies (PSG) during their hospital stay, under 20 L/min and 35 L/min NHF therapy in randomized order.; Primary objective is the mean overnight transcutaneous PCO2 value, absolute as well as time spent >50 mmHg.	baseline
Primary	mean overnight transcutaneous PCO2	In home care monitoring is the aim to compare long term influences of NHF and LOT on PCO2 levels. Primary objective is the mean overnight transcutaneous PCO2 level measured after 4 weeks of each treatment phase.	after 4 weeks
Primary	mean overnight transcutaneous PCO2	All patients will be monitored under NHF or another sufficient therapy for the next 12 month followed by another mean overnight transcutaneous PCO2 level measure.	after 12 month
Secondary	quality of life with Saint Georges Respiratory Questionnaire (SGRQ)	SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.	after 4 weeks, 8 weeks and 12 month