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

Neuromuscular Diseases Clinical Trial

— Homerun  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03203577
• Other study ID #: ZonMw 80-83700-98-52003
• Secondary ID: NTR4683METc 2014
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: May 2018

Study information

• Verified date: June 2018
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Initiation of mechanical ventilation
In patient with chronic respiratory insufficient chronic mechanical ventilation will be initiated in the patient his/her setting.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Lung function	evaluate lungfunction in time; with measurments of flow/volume in a sitting and horizontal position	6 months after initation of mechanical ventilation
Secondary	Nocturnal transcutaneous carbon dioxide and saturation	Nocturnal transcutaneous carbon dioxide and saturation in time	6 months after initiation of mechanical ventilation
Secondary	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