Efficacy and Physiology of Nasal High Flow Therapy

NCT02083120 | Completed DMC

• 1 other identifier: AIRVOhome
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

high flow; COPD; AIRVO

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• quality of life with Saint Georges Respiratory Questionnaire (SGRQ)

  after 4 weeks, 8 weeks and 12 month

Other Outcomes (1)

• sleep quality

  baseline, after 4 weeks, after 8 weeks, after 12 month

Study Arms (2)

nasal High Flow and Oxygen

EXPERIMENTAL

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

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

Long term Oxygen Therapy (LOT)

ACTIVE COMPARATOR

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

Other: Long term Oxygen Therapy (LOT)

Interventions

NHF therapy DEVICE

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.

Also known as: AIRVO 2, myAIRVO 2, PT101, PT100

nasal High Flow and Oxygen

Long term Oxygen Therapy (LOT) OTHER

Oxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%.

Also known as: supplemental oxygen

Long term Oxygen Therapy (LOT); nasal High Flow and Oxygen

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Pneumologie Hagen Ambrock eV: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Helios Klinik Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

Location

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

• Georg Nilius, MD

  Helios Klinik Ambrock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of pneumologic department of Helios Klinik Hagen

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 11, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

DE (1)