Initiation of Long-term Non-invasive Ventilation in COPD

NCT02652559 | Completed DMC

• 1 other identifier: 201600008
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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. 1.To investigate whether home initiation of chronic NIV in stable COPD patients with CHRF is non-inferior to inpatient initiation.
2. 2.To investigate predictors of a favourable response to chronic NIV in COPD patients with CHRF.
3. 3.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.
4. 4.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

Keywords

Chronic Obstructive Pulmonary Disease; Non-invasive ventilation; Home initiation

Outcome Measures

Primary Outcomes (1)

• Change in daytime PaCO2

  An arterial function will be performed during spontaneous breathing without oxygen after 6 months.

  Baseline, 6 months

Secondary Outcomes (9)

• Change in FEV1

  Baseline, 6 months

• Change in health-related quality of life (HRQoL)

  Baseline, 6 months

• Incremental cost-utility ratio

  Baseline, 6 months

• Number of participants with treatment-related adverse events

  Baseline, 3 months and 6 months

• Compliance

  Baseline, 3 months and 6 months

Study Arms (2)

Home initiation

EXPERIMENTAL

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; Device: Telemonitoring; Device: EMG; Other: Home initiation of NIV

Inhospital initiation

ACTIVE COMPARATOR

Inhospital initiation of NIV is standard care and in the study will be set as the control arm.

Device: Transcutaneous measurements of PCO2; Device: EMG; Other: Inhospital initiation of NIV

Interventions

Transcutaneous measurements of PCO2 DEVICE

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)

Home initiation; Inhospital initiation

Telemonitoring DEVICE

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.

Home initiation

EMG DEVICE

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

Home initiation; Inhospital initiation

Home initiation of NIV OTHER

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

Home initiation

Inhospital initiation of NIV OTHER

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

Inhospital initiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

• Duiverman ML, Vonk JM, Bladder G, van Melle JP, Nieuwenhuis J, Hazenberg A, Kerstjens HAM, van Boven JFM, Wijkstra PJ. Home initiation of chronic non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure: a randomised controlled trial. Thorax. 2020 Mar;75(3):244-252. doi: 10.1136/thoraxjnl-2019-213303. Epub 2019 Sep 4.

  PMID: 31484786 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marieke Duiverman, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 12, 2016
• Study Start: June 1, 2016
• Primary Completion: July 25, 2018
• Study Completion: July 25, 2018
• Last Updated: December 17, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)