Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* Resides within either a 5-mile or 20 minute driving radius of emergency department
* Has capacity to consent to study OR can assent to study and has proxy who can consent
* \>= 18 years-old
* Can identify a potential caregiver who agrees to stay with patient for first 24 hours of admission. Caregiver must be competent to call care team if a problem is evident to her/him. After 24 hours, this caregiver should be available for as-needed spot checks on the patient. This criterion may be waived for highly competent patients at the patient and clinician's discretion.
* Primary or possible diagnosis of cellulitis, heart failure, complicated urinary tract infection, pneumonia, COPD/asthma, other infection, chronic kidney disease, malignant pain, diabetes and its complications, gout flare, hypertensive urgency, previously diagnosed atrial fibrillation with rapid ventricular response, anticoagulation needs, or a patient who desires only medical management that requires inpatient admission, as determined by the emergency room team.

Exclusion Criteria:

* Undomiciled
* No working heat (October-April), no working air conditioning if forecast \> 80°F (June-September), or no running water
* On methadone requiring daily pickup of medication
* In police custody
* Resides in facility that provides on-site medical care (e.g., skilled nursing facility)
* Domestic violence screen positive
* Acute delirium, as determined by the Confusion Assessment Method
* Cannot establish peripheral access in emergency department (or access requires ultrasound guidance)
* Secondary condition: end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
* Primary diagnosis requires multiple or routine administrations of intravenous narcotics for pain control
* Cannot independently ambulate to bedside commode
* As deemed by on-call medical doctor, patient likely to require any of the following procedures: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery
* High risk for clinical deterioration
* Home hospital census is full (maximum 5 patients at any time)
B: Inclusion Criteria:

* Resides within 5-mile radius of emergency room
* English- or Spanish-speaker
* Can identify a potential caregiver who agrees to stay with patient for first 24 hours of admission. Caregiver must be competent to call care team if a problem is evident to her/him.
* This criterion may be waived for highly competent patients at the patient and clinician's discretion.
* \>=18 years old
* Primary diagnosis of cellulitis, heart failure, complicated urinary tract infection, or pneumonia that requires inpatient admission as determined by blinded emergency room team.

Exclusion Criteria:

* Undomiciled
* No working heat (October-April), no working air conditioning if forecast \> 80°F (June-September), or no running water
* On methadone requiring daily pickup of medication
* In police custody
* Resides in facility that provides on-site medical care (e.g., skilled nursing facility)
* Domestic violence screen positive
* Cared for by a private primary care physician who rounds in the hospital
* Cannot establish peripheral access in emergency department (or access requires ultrasound guidance)
* Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
* Primary diagnosis requires narcotics for pain control
* Cannot independently ambulate to bedside commode
* As deemed by on-call medical doctor, patient likely to require any of the following procedures: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery
* For pneumonia:
* Most recent CURB65 \> 3: new confusion, blood urea nitrogen \> 19mg/dL, respiratory rate\>=30/min, systolic blood pressure\<90mmHg, Age\>=65
* Most recent SMRTCO \> 2: systolic blood pressure \< 90mmHg (2pts), multilobar chest xray involvement (1pt), respiratory rate \>= 30/min, heart rate \>= 125, new confusion, oxygen saturation \<= 90%
* Absence of clear infiltrate on imaging
* Cavitary lesion on imaging
* O2 saturation \< 90% despite 5L O2
* For heart failure:
* Has a left ventricular assist device or paced rhythm
* Get with the Guidelines - Heart Failure (\>10% in-hospital mortality) or The Acute Decompensated Heart Failure National Registry score (high risk or intermediate risk 1)
* Anasarca
* Pulmonary hypertension
* For complicated urinary tract infection:
* Absence of pyuria
* Most recent quick sepsis related organ failure assessment \> 1
* Home hospital census is full (maximum 4 patients at any time)
C: Inclusion Criteria:

* An acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding (ICB)) with the signs and symptoms of an acute stroke according to the World Health Organisation definition of acute stroke14 within the last 12 hours without the need or possibility of a neurosurgical intervention
* No thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial
* The informed consent of the patient or, if not possible, of the relatives
* Living at home before the event
* Lack of participation in another trial.

Exclusion Criteria:

* Thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial
* No informed consent of the patient or, if not possible, of the relatives
* Not living at home before the event
* Participation in another trial (26 patients were excluded because of TIA with full recovery within 24 hours after the event)
D: This study will be set up in COPD patients with CHRF who were referred to our centre to start chronic NIV.

Inclusion criteria:

* Indication to initiate chronic NIV in COPD patients (GOLD stage III or IV: FEV1/ forced vital capacity (FVC)\< 70% and FEV1\< 50% predicted; PaCO2 \> 6.0 kPa in stable condition, which means no COPD exacerbation for 4 weeks and a pH \> 7.35)
* Age \> 18 years
* Existence of a sufficient social support network making initiation of HMV at home possible and safe.

Exclusion Criteria:

* Instable severe cardiac comorbidities (left ventricular ejection fraction below 45%, instable angina pectoris complaints)
* Patients admitted to a nursing home

Answer: D