Status:
UNKNOWN
Validation of the "ExSpiron©" in Patients With ALS
Lead Sponsor:
University Medical Center Groningen
Conditions:
Amyotrophic Lateral Sclerosis
Neuromuscular Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Non-invasive ventilation (NIV) in patients diagnosed with amyotrophic lateral sclerosis (ALS) is nowadays common practice to provide comfort at the end stage of the disease. As complaints vary there i...
Detailed Description
Rationale: Non-invasive ventilation (NIV) in patients diagnosed with amyotrophic lateral sclerosis (ALS) is nowadays common practice to provide comfort at the end stage of the disease. As complaints v...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Participants diagnosed with ALS requiring NIV
- Age \> 18 of age; \< 85 years of age
- An indication to start chronic NIV, hypercapnic respiratory failure (arterial carbon dioxide PaCO2 \> 6.0 kilo pascal (kPa) measured during daytime) or orthopnoea due to diaphragm paralysis.
- Participants are able to provide feedback
- Participants that are willing to participate and are able to consent and sign the informed consent form.
Exclusion
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Clinically unstable
- Acute respiratory failure
- Participants with refractory hypotension, defined as systolic blood pressure less than 90 mmHg, despite inotropic agents
- Uncontrolled cardiac ischemia or arrhythmias
- Participants suffering from metastatic or terminal cancer
- Other comorbid disease affecting respiration (ie obstructive sleep apnea, chronic obstructive pulmonary disease)
- Participants lacking functional medical decision-making
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04089696
Start Date
September 1 2025
End Date
September 1 2025
Last Update
November 29 2023
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