N/A Completed N=23 Randomized Single-blind Treatment

Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients

Nocturnal Hypoventilation · Neuromuscular Disease · Chest Wall Disorder

Source: ClinicalTrials.gov NCT00901485 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcomePrimary: Overnight Mean Oxygen Saturation — 96; 96 % SaO2 — p=0.13

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.