Chronic Obstructive Pulmonary Disease Clinical Trial
— RECONSIDEROfficial title:
Treatment of Chronic Respiratory Failure in COPD Patients With Non-invasive Ventilation: Starting at Home and Selecting the Right Patient
NCT number | NCT02652559 |
Other study ID # | 201600008 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | July 25, 2018 |
Verified date | December 2018 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 67 |
Est. completion date | July 25, 2018 |
Est. primary completion date | July 25, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in daytime PaCO2 | An arterial function will be performed during spontaneous breathing without oxygen after 6 months. | Baseline, 6 months | |
Secondary | Change in FEV1 | Change in FEV1, assessed by spirometry, according to the ERS guidelines. | Baseline, 6 months | |
Secondary | Change in health-related quality of life (HRQoL) | HRQoL will be assessed by the Severe Respiratory Insufficiency (SRI) questionnaire. The SRI is a well-known and validated HRQoL questionnaire especially designed for patients with CHRF on HMV. | Baseline, 6 months | |
Secondary | Incremental cost-utility ratio | In the economic evaluation, the primary aim will be to estimate the direct medical costs of the initiation at home compared to the current national guideline of initiating ventilatory support in the hospital. Cost-effectiveness will be investigated by estimating the healthcare costs of home initiation and usual care and the HRQoL gains of the two options. For the purpose of estimating HRQoL gains both the SRI and the EuroQol (EQ-5D) will be assessed, at baseline and after six months follow up. The incremental cost-utility ratio (ICUR) will be calculated | Baseline, 6 months | |
Secondary | Number of participants with treatment-related adverse events | Treatment related adverse events are aerophagia, mask-related problems (skin irritation) or excessive mask leaks. | Baseline, 3 months and 6 months | |
Secondary | Compliance | Compliance with the home ventilator will be read from ventilator counter readings. The mean number of hours use per day is registered. | Baseline, 3 months and 6 months | |
Secondary | Change in exercise tolerance | Exercise tolerance will be assessed with the 6-minute walking test, performed according to the European Respiratory Society/American Thoracic Society guidelines, along a 30 m indoor course, with standardised encouragements given by the investigator. Oxygen will be prescribed in the regular amount advised to the patient during exercise. Oxygen saturation, heart rate, and Borg dyspnoea scores will be assessed prior to the test and at the end of the test for safety reasons. The outcome will be the number of meters walked. | Baseline, 6 months | |
Secondary | Change in hyperinflation | Hyperinflation will be assessed by measuring total lung capacity (TLC) and residual volume (RV), and assessing the RV%TLC ratio, according to the ERS guidelines | Baseline, 6 months | |
Secondary | Change in diffusion capacity | Diffusion capacity will be assessed by measuring carbon monoxide transfer factor, according to the ERS guidelines | Baseline, 6 months | |
Secondary | Change in PaCO2 | An arterial function will be performed during spontaneous breathing without oxygen after 3 months. | Baseline, 3 months |
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