Status:
COMPLETED
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
Lead Sponsor:
ResMed
Collaborating Sponsors:
University Hospital, Essen
Conditions:
Respiratory Insufficiency
Sleep Disordered Breathing
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Detailed Description
Persisting ventilatory failure associated with chronic obstructive pulmonary disease (COPD), obesity-hypoventilation-syndrome, sleep apnoea or neuromuscular disease is increasingly managed with domici...
Eligibility Criteria
Inclusion
- 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 \<75years.
- Previously shown to have a requirement for an EEP above cm H2O in order to maintain upper airway patency, or those in whom such a raised EEP would be expected, e.g. obese patients.
- Patients also known to have adequate airway patency at an EEP of 4 to 5 cm H2O will be included to ensure specificity of the algorithm.
Exclusion
- Acute critical illness (e.g. acute coronary syndrome, stroke)
- Serious anatomical variations of nose, sinuses, pharynx or oesophagus.
- Any condition at risk of oesophageal bleeding (e.g. oesophageal varices, gastric ulcer, etc.)
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01403584
Start Date
July 1 2011
End Date
February 1 2015
Last Update
March 26 2021
Active Locations (1)
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1
Abteilung Pneumologie - Universitätsklinik, Ruhrlandklinik
Essen, Germany, 45239