Initiation of Home Mechanical Ventilation at Home in Patients With Chronic Hypercapnic Respiratory Failure (Homerun)

Initiation of Home Mechanical Ventilation at Home in a Selectve Group of Patients With Chronic Hypercapnic Respiratory Failure in the Netherlands

Objective: To prove that initiation of chronic ventilatory support at home, in patients with chronic hypercapnic respiratory failure due to neuromuscular disease (NMD) or thoracic cage problem is not inferior compared to initiation in a hospital based setting. In addition we believe that the start at home is cheaper compared to an in-hospital start.

Hypothesis: Initiation of chronic ventilatory support at home is effective, safe and cost effective compared to a hospital-based initiation.

Study design: A nationwide non-inferiority multi-center randomized parallel active control study.

Study population: Patients with chronic respiratory insufficiency due to a neuromuscular disease (NMD) or thoracic cage problem who are referred for chronic ventilator support.

Intervention: The start of HMV at home Standard intervention to be compared to: The start of HMV is normally in a clinical setting as recommended in the national guideline.

Outcome measures: Primary: PaCO2. Secondary: Health related quality of life; lung function; nocturnal transcutaneous carbon dioxide assessment and saturation, and costs Sample size calculation/data analysis: This is a non-inferiority trial based on PaCO2 as primary outcome. A difference in favor of the hospital care group of smaller than 0.5 kPa will be labeled as non-inferior. To retain 72 evaluable patients, and allow for drop-outs, we will include 96 patients in total.

Cost-effectiveness analysis: A cost analysis will be conducted alongside the clinical trial. Costs of the initiation of HMV at home and in the hospital will be estimated form a societal perspective over a time horizon of 6 months.

Time schedule: After an initial phase of 6 months recruitment will start and will take 24 months. Thirty-six months after the start of the study the last assessments will be done and analysis and writing of the papers will start. After 42 months the study will end.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Diseases; Respiration, Artificial; Noninvasive Ventilation; Cost-Benefit Analysis; Positive-Pressure Respiration; Respiratory Therapy; Ambulatory Monitoring
• Intervention / Treatment: Procedure: Initiation of mechanical ventilation

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9700 RB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Indication to initiate non-invasive ventilatory support in patients with a neuromuscular disease or thoracic cage abnormality who suffer from complaints of alveolar hypoventilation (fatigue, headache of dyspnoea) combined with all following elements:
• arterial carbon dioxide > 6.0 kPa daytime or arterial or transcutaneous carbon dioxide > 6.0 kPa at night or orthopnea as a result of diaphragm paralysis
• Age > 18 years
• Existence, of a sufficient network (social or professional) according to the supervising HMV center making initiation of HMV at home possible and safe.

Exclusion Criteria:

• Patients who already have had HMV due to acute respiratory failure
• Necessity for invasive ventilatory support
• Patients admitted to a nursing home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hospital initiation; Initiation of mechanical ventilation in hospital initiation of Home Mechanical ventilation takes place in a hospital; this makes this arm the standard care.	Procedure: Initiation of mechanical ventilation; In patient with chronic respiratory insufficient chronic mechanical ventilation will be initiated in the patient his/her setting.; Other Names: start of home mechanical ventialtion with telemonitoring
Experimental: Home initiation; Initiation of mechanical ventilation at home Initiation of mechanical ventilation in a patient's home setting with telemonitoring	Procedure: Initiation of mechanical ventilation; In patient with chronic respiratory insufficient chronic mechanical ventilation will be initiated in the patient his/her setting.; Other Names: start of home mechanical ventialtion with telemonitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime arterial carbon dioxide	Daytime arterial carbon dioxide (PaCO2) assessed without oxygen supplementation and ventilatory support while the patient is in sitting position	6 months after initiation of mechanical ventilation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Health related quality of life by using the following questionnaires: SF 36, MRF 28, HADS, SRI	6 months after initiation of mechanical ventilation
Lung function	evaluate lungfunction in time; with measurments of flow/volume in a sitting and horizontal position	6 months after initation of mechanical ventilation
Nocturnal transcutaneous carbon dioxide and saturation	Nocturnal transcutaneous carbon dioxide and saturation in time	6 months after initiation of mechanical ventilation
costs	evaluation of the costs during initiation and the follow-up for 6 months. This will be objective by using the EuroQol (EQ-5D) questionnaire	6 months after initiation of mechanical ventilation

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: P.J. Wijkstra, Prof., University Medical Center Groningen

Publications and helpful links

General Publications

• van den Biggelaar RJM, Hazenberg A, Cobben NAM, Gaytant MA, Vermeulen KM, Wijkstra PJ. A Randomized Trial of Initiation of Chronic Noninvasive Mechanical Ventilation at Home vs In-Hospital in Patients With Neuromuscular Disease and Thoracic Cage Disorder: The Dutch Homerun Trial. Chest. 2020 Dec;158(6):2493-2501. doi: 10.1016/j.chest.2020.07.007. Epub 2020 Jul 16.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 29, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Neuromuscular Diseases
• Other Study ID Numbers: ZonMw 80-83700-98-52003; NTR4683 (Registry Identifier: Dutch trial registry); METc 2014.529 (Other Identifier: Medical ethical committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO