N/A
Completed N=21
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
Respiratory Insufficiency · sleep-disordered breathing
Source: ClinicalTrials.gov NCT01403584 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI) — 1.3; 1.7 Events per hour of sleep
Summary
The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure. For this purpose, The investigators will study different groups of patients, including those with obstructive and restrictive ventilatory defect, and obstructive sleep apnoea, non-naive to conventional bi-level positive airways pressure therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI) |
1.3; 1.7 | — |
| SECONDARY Mean SpO2 |
92; 93 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects will be patients not naive to noninvasive ventilation, and being so treated for any form of hypercapnic ventilatory failure.
- Previously stabilised on bilevel noninvasive pressure support ventilation.
- Both genders, age 75 years
- Pregnancy
- Epilepsy
- Psychiatric disorders that could possibly influence the study
- Any kind of addiction
- Insufficient knowledge of the language
- Noninvasive ventilation otherwise contraindicated
Data sourced from ClinicalTrials.gov (NCT01403584). 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.