Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
Adjustment of Non-invasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Ventilatory Failure Using Automated End-expiratory Pressure (AutoEEP) Algorithm
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Persisting ventilatory failure associated with chronic obstructive pulmonary disease (COPD), obesity-hypoventilation-syndrome, sleep apnoea or neuromuscular disease is increasingly managed with domiciliary non-invasive positive pressure ventilation (NIPPV).
Optimal settings of non-invasive ventilation are usually titrated manually and require time and expertise. The development of systems lead to automated analysis and development of algorithms to adjust ventilators. However, there is a paucity of optimal algorithms, particularly the problem of upper airway obstruction. Therefore, the central aim of this study is to develop the automated setting of an end-expiratory positive airway pressure (EPAP), because upper airway obstruction is relatively common in this group of patients. We hypothesise that an automated end-expiratory airway pressure (AutoEEP) adjusting algorithm could overcome these problems and further optimise and adjust ventilator settings. Using non-invasive ventilation in patients with hypercapnic ventilatory failure, awake and asleep, we will measure physiological outcome parameters and apply an AutoEEP algorithm, comparing it against usual care.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Essen, Tyskland, 45239
- Abteilung Pneumologie - Universitätsklinik, Ruhrlandklinik
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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 <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 Criteria:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: AutoVPAP with addition of AutoEPAP
This arm will receive conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure.
Patients randomised to this group will then receive the other treatment the following night.
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Implementation of automated algorithm for adjustment of conventional device parameter (EPAP0.
Conventionally applied Expiratory Positive Airway Pressure (EPAP)
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Aktiv komparator: AutoVPAP without addition of AutoEPAP
This arm will receive conventionally applied Expiratory Positive Airway Pressure.
Patients randomised to this group will then receive the other treatment the following night.
|
Implementation of automated algorithm for adjustment of conventional device parameter (EPAP0.
Conventionally applied Expiratory Positive Airway Pressure (EPAP)
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI)
Tidsram: On completion of each consecutive night of polysomnography.
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The AHI is a count of the number of pauses during sleep a person experiences.
The total number of apneas/ hypopneas (sleep pauses) are divided by the total sleep time to get an index for that night
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On completion of each consecutive night of polysomnography.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Mean SpO2
Tidsram: On completion of each night of 2 consecutive nights polysomnography.
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During sleep, pulse oximetery is recorded through a sensor on the participants finger
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On completion of each night of 2 consecutive nights polysomnography.
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Helmut Teschler, Dr. med., Abteilung Pneumologie - Universitätsklinik, Essen, Germany
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 09-4225
Plan för individuella deltagardata (IPD)
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