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Trial record 48 of 668 for:    CARBON DIOXIDE AND arterial

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

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ClinicalTrials.gov Identifier: NCT03203577
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Wijkstra, University Medical Center Groningen

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
Respiratory Therapy Respiration, Artificial Positive-Pressure Respiration Neuromuscular Diseases Noninvasive Ventilation Cost-Benefit Analysis Ambulatory Monitoring Procedure: Initiation of mechanical ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : July 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: start of home mechanical ventialtion with telemonitoring




Primary Outcome Measures :
  1. Daytime arterial carbon dioxide [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 months after initiation of mechanical ventilation ]
    Nocturnal transcutaneous carbon dioxide and saturation in time

  4. costs [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203577


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: P.J. Wijkstra, Prof. University Medical Center Groningen

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Responsible Party: Peter Wijkstra, professor, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT03203577     History of Changes
Other Study ID Numbers: ZonMw 80-83700-98-52003
NTR4683 ( Registry Identifier: Dutch trial registry )
METc 2014.529 ( Other Identifier: Medical ethical committee )
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Neuromuscular Diseases
Respiration Disorders
Respiratory Tract Diseases
Nervous System Diseases