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

NCT ID: NCT03203577

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2018-05-31

Brief Summary

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.

Conditions

Respiratory Therapy; Respiration, Artificial; Positive-Pressure Respiration; Neuromuscular Diseases; Noninvasive Ventilation; Cost-Benefit Analysis; Ambulatory Monitoring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Initiation of mechanical ventilation

Intervention Type: PROCEDURE

In patient with chronic respiratory insufficient chronic mechanical ventilation will be initiated in the patient his/her setting.

Home initiation

Initiation of mechanical ventilation at home Initiation of mechanical ventilation in a patient's home setting with telemonitoring

Group Type: EXPERIMENTAL

Initiation of mechanical ventilation

Intervention Type: PROCEDURE

In patient with chronic respiratory insufficient chronic mechanical ventilation will be initiated in the patient his/her setting.

Interventions

Initiation of mechanical ventilation

In patient with chronic respiratory insufficient chronic mechanical ventilation will be initiated in the patient his/her setting.

Intervention Type: PROCEDURE

Other Intervention Names

start of home mechanical ventialtion with telemonitoring

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Peter Wijkstra

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

P.J. Wijkstra, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 32682770 (View on PubMed)

Other Identifiers

NTR4683

Identifier Type: REGISTRY

Identifier Source: secondary_id

METc 2014.529

Identifier Type: OTHER

Identifier Source: secondary_id

ZonMw 80-83700-98-52003

Identifier Type: -

Identifier Source: org_study_id