Initiation of Long-term Non-invasive Ventilation in COPD

Summary

Rationale:

Application of long-term non-invasive ventilation (NIV) in stable chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been shown to improve survival and quality of life when applied with sufficiently high inspiratory pressures and adequate backup breathing frequencies (so called high-intensity NIV). However, for a broader implementation of this therapy in a potentially large group of patients, important issues have to be solved. First, the initiation of high-intensity NIV, currently performed in the hospital, is often time-consuming, expensive and inconvenient for patients. Secondly, although clinicians recognise that not all patients benefit, it is not known which factors predict a positive response.

Objectives:

1. To investigate whether home initiation of chronic NIV in stable COPD patients with CHRF is non-inferior to inpatient initiation.
2. To investigate predictors of a favourable response to chronic NIV in COPD patients with CHRF.

Study design:

The study is 1:1 two-arm parallel group randomised controlled trial comparing the usual inpatient NIV initiation to home initiation.

Study population: Seventy-two COPD patients with a NIV indication (COPD GOLD stage III or IV; partial arterial carbon dioxide pressure (PaCO2) \> 6.0 kPa in stable condition, i.e. no COPD exacerbation for 4 weeks and a pH \> 7.35), a sufficient social network at home, without severe cardiac comorbidities, will be included.

Intervention: Home initiation of NIV will be compared with standard in-hospital initiation. NIV at home will be titrated by a specialised nurse of our home mechanical ventilation centre (HMV) on transcutaneously measured gas exchange and respiratory electromyography and will be adjusted with the use of telemedicine.

Main study parameters/endpoints:

1. To investigate non-inferiority of home initiation, the change in arterial carbon dioxide pressure after 3 months treatment will be the primary outcome. Secondary outcomes are safety, change in lung function, health-related quality of life (HRQoL) and costs.
2. To investigate predictors of a favourable response, patient demographics, and baseline data on lung function as well as measures of respiratory muscle activity, arterial blood gases, comorbidities, inflammatory blood markers and anxiety and depressions scores will be collected of all patients.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

DEVICE

Transcutaneous measurements of PCO2

PCO2 will be measured transcutaneously with an ear lobe sensor before initiation of NIV, and during the initiation period (SenTec DM®, Software V-STATS 4.0; SenTec AG; Therwil, Switzerland)

DEVICE

Telemonitoring

Telemonitoring will be used to send data from the transcutaneous measurements, data from the EMG measurements and data from the ventilator from home to the hospital.

DEVICE

EMG

Surface EMG of the respiratory muscles will be used to monit patients in both groups as a surrogate marker of respiratory muscle unloading and to detect PVA during NIV

OTHER

Home initiation of NIV

The primary aim of the study is to compare home and inhospital initiation of NIV

OTHER

Inhospital initiation of NIV

The primary aim of the study is to compare home and inhospital initiation of NIV

Sponsors & Collaborators

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Marieke Duiverman, MD PhD · University Medical Center Groningen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2018-07-25

Completion

2018-07-25

Countries

• Netherlands

Study Locations