N/A
N=23
Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients
Nocturnal Hypoventilation · Neuromuscular Disease · Chest Wall Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00901485 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Overnight Mean Oxygen Saturation — 96; 96 % SaO2 — p=0.13
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AutoVPAP (Device); VPAPIIIST-A (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overnight Mean Oxygen Saturation |
96; 96 | 0.13 |
| SECONDARY Overnight Mean Transcutaneous Carbon Dioxide |
6.5; 6.2 | 0.54 |
| SECONDARY Overnight Peak Transcutaneous Carbon Dioxide |
7.1; 6.9 | 0.94 |
| SECONDARY Oxygen Desaturation Index (>4%) |
2.5; 5.0 | 0.42 |
| SECONDARY Sleep Quality: Arousal Index |
17; 14 | 0.82 |
Summary
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal hypoventilation who have never experienced nocturnal, home NIV.
Eligibility Criteria
Inclusion Criteria
- new clinical diagnosis of nocturnal hypoventilation
- requirement for long-term domiciliary non-invasive ventilation
- no previous experience with domiciliary non-invasive ventilation
Exclusion Criteria
- uncontrolled cardiac failure
- acute exacerbation of respiratory failure
- daytime resting PaO2 < 7.5kPa
- moderate or severe bulbar weakness
- inability to understand rationale and/or consent form for study
Data sourced from ClinicalTrials.gov (NCT00901485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.