Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Treatment of Chronic Respiratory Failure in COPD Patients With Non-invasive Ventilation: Starting at Home and Selecting the Right Patient
Brief 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.


Options:
A: Arm Label: Inpatient hospitalization; Type: ACTIVE_COMPARATOR; Interventions: Other: Traditional inpatient hospitalization | Arm Label: Home hospitalization; Type: EXPERIMENTAL; Interventions: Other: Home hospitalization | Intervention Type: OTHER; Name: Home hospitalization; Assigned to Arm(s): Home hospitalization | Intervention Type: OTHER; Name: Traditional inpatient hospitalization; Assigned to Arm(s): Inpatient hospitalization
B: Arm Label: Inpatient hospitalization; Type: ACTIVE_COMPARATOR; Interventions: Other: Inpatient Hospitalization | Arm Label: Home hospitalization; Type: EXPERIMENTAL; Interventions: Other: Home hospitalization | Intervention Type: OTHER; Name: Home hospitalization; Assigned to Arm(s): Home hospitalization | Intervention Type: OTHER; Name: Inpatient Hospitalization; Assigned to Arm(s): Inpatient hospitalization
C: Intervention Type: PROCEDURE; Name: structured therapeutic chain of stroke treatment; Assigned to Arm(s): N/A
D: Arm Label: Home initiation; Type: EXPERIMENTAL; Interventions: Device: Transcutaneous measurements of PCO2, Device: Telemonitoring, Device: EMG, Other: Home initiation of NIV | Arm Label: Inhospital initiation; Type: ACTIVE_COMPARATOR; Interventions: Device: Transcutaneous measurements of PCO2, Device: EMG, Other: Inhospital initiation of NIV | Intervention Type: DEVICE; Name: Transcutaneous measurements of PCO2; Assigned to Arm(s): Home initiation, Inhospital initiation | Intervention Type: DEVICE; Name: Telemonitoring; Assigned to Arm(s): Home initiation | Intervention Type: DEVICE; Name: EMG; Assigned to Arm(s): Home initiation, Inhospital initiation | Intervention Type: OTHER; Name: Home initiation of NIV; Assigned to Arm(s): Home initiation | Intervention Type: OTHER; Name: Inhospital initiation of NIV; Assigned to Arm(s): Inhospital initiation

Answer: D