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

NCT03203577 | Completed DMC

• 3 other identifiers: ZonMw 80-83700-98-52003NTR4683METc 2014.529
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of life

  6 months after initiation of mechanical ventilation

• Lung function

  6 months after initation of mechanical ventilation

• Nocturnal transcutaneous carbon dioxide and saturation

  6 months after initiation of mechanical ventilation

• costs

  6 months after initiation of mechanical ventilation

Study Arms (2)

Hospital initiation

ACTIVE COMPARATOR

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

Home initiation

EXPERIMENTAL

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

Procedure: Initiation of mechanical ventilation

Interventions

Initiation of mechanical ventilation PROCEDURE

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

Also known as: start of home mechanical ventialtion with telemonitoring

Home initiation; Hospital 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 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.

You may not qualify if:

• Patients who already have had HMV due to acute respiratory failure
• Necessity for invasive ventilatory support
• 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)

• 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.

  PMID: 32682770 DERIVED

MeSH Terms

Conditions

Respiratory Aspiration; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• P.J. Wijkstra, Prof.

  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: professor

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: June 29, 2017
• Study Start: July 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2018
• Last Updated: June 18, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)