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

Sponsor
University Medical Center Groningen (Other)
Overall Status
Completed
CT.gov ID
NCT03203577
Collaborator
(none)
96
Enrollment
1
Location
2
Arms
34
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Initiation of mechanical ventilation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Initiation of Home Mechanical Ventilation at Home in a Selectve Group of Patients With Chronic Hypercapnic Respiratory Failure in the Netherlands
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Daytime arterial carbon dioxide [6 months after initiation of mechanical ventilation]

      Daytime arterial carbon dioxide (PaCO2) assessed without oxygen supplementation and ventilatory support while the patient is in sitting position

    Secondary Outcome Measures

    1. Quality of life [6 months after initiation of mechanical ventilation]

      Health related quality of life by using the following questionnaires: SF 36, MRF 28, HADS, SRI

    2. Lung function [6 months after initation of mechanical ventilation]

      evaluate lungfunction in time; with measurments of flow/volume in a sitting and horizontal position

    3. Nocturnal transcutaneous carbon dioxide and saturation [6 months after initiation of mechanical ventilation]

      Nocturnal transcutaneous carbon dioxide and saturation in time

    4. costs [6 months after initiation of mechanical ventilation]

      evaluation of the costs during initiation and the follow-up for 6 months. This will be objective by using the EuroQol (EQ-5D) questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Groningen Groningen Netherlands 9700 RB

    Sponsors and Collaborators

    • University Medical Center Groningen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peter Wijkstra, professor, University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT03203577
    Other Study ID Numbers:
    • ZonMw 80-83700-98-52003
    • NTR4683
    • METc 2014.529
    First Posted:
    Jun 29, 2017
    Last Update Posted:
    Jun 18, 2018
    Last Verified:
    Jun 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Respiratory Insufficiency
    Neuromuscular Diseases

    Study Results

    No Results Posted as of Jun 18, 2018