Comparing outpatient and inpatient initiation of home mechanical ventilation for ALS patients
Ambulatory Versus Inpatient Initiation of Home Non-invasive Mechanical Ventilation in Patient With Amyotrophic Lateral Sclerosis: a Prospective, Noninferiority Randomized Controlled Trial (The NIB-study)
This study is testing if starting home breathing support for ALS patients at an outpatient clinic works just as well as starting it in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (GLostrup) |
| Trial ID | NCT05829330 on ClinicalTrials.gov |
What this trial studies
This investigation aims to determine if starting noninvasive home mechanical ventilation in an outpatient setting, along with closed telemonitoring and follow-up, is as effective as beginning treatment during a hospital stay for patients with amyotrophic lateral sclerosis (ALS). The study will assess the non-inferiority of the outpatient approach compared to traditional inpatient initiation. By evaluating patient outcomes, the research seeks to provide insights into the best practices for managing ALS-related respiratory issues.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with amyotrophic lateral sclerosis who require non-invasive mechanical ventilation.
Not a fit: Patients who are indicated for invasive mechanical ventilation or those who cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more convenient and potentially safer method for ALS patients to initiate home mechanical ventilation.
How similar studies have performed: While the specific approach of outpatient initiation with telemonitoring is novel, similar studies have shown promising results in improving patient outcomes in respiratory care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Diagnosed with amyotrophic lateral sclerosis * Indication for start of non-invasive mechanical ventilation Exclusion Criteria: * No informed consent * Does not understand Danish or English * Indication for invasive mechanical ventilation * No morning baseline PCO2 * Hospitalization
Where this trial is running
GLostrup
- Department of Anaesthesia, Pain and REspiratory Support — GLostrup, Denmark (Recruiting)
Study contacts
- Study coordinator: Anne Kathrine Staehr-Rye, MD
- Email: Anne.kathrine.staehr.rye@regionh.dk
- Phone: 004538683868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.