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Initiation of Long-term Non-invasive Ventilation in COPD (RECONSIDER)

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ClinicalTrials.gov Identifier: NCT02652559
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Marieke Duiverman, University Medical Center Groningen

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Device: Transcutaneous measurements of PCO2 Device: Telemonitoring Device: EMG Other: Home initiation of NIV Other: Inhospital initiation of NIV Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Chronic Respiratory Failure in COPD Patients With Non-invasive Ventilation: Starting at Home and Selecting the Right Patient
Actual Study Start Date : June 2016
Actual Primary Completion Date : July 25, 2018
Actual Study Completion Date : July 25, 2018

Arm Intervention/treatment
Experimental: Home initiation
Home initiation of long-term 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.
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

Active Comparator: Inhospital initiation
Inhospital initiation of NIV is standard care and in the study will be set as the control arm.
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: 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: Inhospital initiation of NIV
The primary aim of the study is to compare home and inhospital initiation of NIV




Primary Outcome Measures :
  1. Change in daytime PaCO2 [ Time Frame: Baseline, 6 months ]
    An arterial function will be performed during spontaneous breathing without oxygen after 6 months.


Secondary Outcome Measures :
  1. Change in FEV1 [ Time Frame: Baseline, 6 months ]
    Change in FEV1, assessed by spirometry, according to the ERS guidelines.

  2. Change in health-related quality of life (HRQoL) [ Time Frame: Baseline, 6 months ]
    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.

  3. Incremental cost-utility ratio [ Time Frame: Baseline, 6 months ]
    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

  4. Number of participants with treatment-related adverse events [ Time Frame: Baseline, 3 months and 6 months ]
    Treatment related adverse events are aerophagia, mask-related problems (skin irritation) or excessive mask leaks.

  5. Compliance [ Time Frame: Baseline, 3 months and 6 months ]
    Compliance with the home ventilator will be read from ventilator counter readings. The mean number of hours use per day is registered.

  6. Change in exercise tolerance [ Time Frame: Baseline, 6 months ]
    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.

  7. Change in hyperinflation [ Time Frame: Baseline, 6 months ]
    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

  8. Change in diffusion capacity [ Time Frame: Baseline, 6 months ]
    Diffusion capacity will be assessed by measuring carbon monoxide transfer factor, according to the ERS guidelines

  9. Change in PaCO2 [ Time Frame: Baseline, 3 months ]
    An arterial function will be performed during spontaneous breathing without oxygen after 3 months.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652559


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Marieke Duiverman, MD PhD University Medical Center Groningen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marieke Duiverman, Dr., University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02652559     History of Changes
Other Study ID Numbers: 201600008
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Marieke Duiverman, University Medical Center Groningen:
Chronic Obstructive Pulmonary Disease
Non-invasive ventilation
Home initiation
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases