Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital, Essen | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AutoVPAP with addition of AutoEPAP | Experimental | 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. |
|
| AutoVPAP without addition of AutoEPAP | Active Comparator | This arm will receive conventionally applied Expiratory Positive Airway Pressure. Patients randomised to this group will then receive the other treatment the following night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AutoVPAP with addition of AutoEPAP | Device | Implementation of automated algorithm for adjustment of conventional device parameter (EPAP0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI) | 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 | On completion of each consecutive night of polysomnography. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean SpO2 | During sleep, pulse oximetery is recorded through a sensor on the participants finger | On completion of each night of 2 consecutive nights polysomnography. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Helmut Teschler, Dr. med. | Abteilung Pneumologie - Universitätsklinik, Essen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abteilung Pneumologie - Universitätsklinik, Ruhrlandklinik | Essen | 45239 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17323049 | Background | Battisti A, Tassaux D, Bassin D, Jolliet P. Automatic adjustment of noninvasive pressure support with a bilevel home ventilator in patients with acute respiratory failure: a feasibility study. Intensive Care Med. 2007 Apr;33(4):632-8. doi: 10.1007/s00134-007-0550-1. Epub 2007 Feb 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Respiratory insufficiency and hypercapnia requiring noninvasive ventilation. Stable on bi-level CPAP. Both genders. Age >18 and <75years. Requiring EPAP >5cmH2O for upper airway patency, or expected to (e.g. obese patients). Some known to have airway patency at EPAP of 5cmH2O will be included to test for falsely positive response.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AutoVPAP With Addition of AutoEPAP | First AutoVPAP With addition of AutoEPAP then AutoVPAP with EPAP Manually Selected Treatment period with conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation. |
| FG001 | AutoVPAP With EPAP Manually Selected | "First AutoVPAP With EPAP Manually Selected then AutoVPAP With Addition of AutoEPAP. A period of treatment using conventionally applied Expiratory Positive Airway Pressure AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Night) |
| |||||||||||||
| Second Intervention(1 Night) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Treatment period with conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Index of Apneoas Plus Hypopnoeas Per Hour of Sleep (AHI) | 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 | Posted | Mean | Standard Deviation | Events per hour of sleep | On completion of each consecutive night of polysomnography. |
|
The intervention took place over 2 nights of polysomnography. No adverse events occurred for any patient on any night polysomnography.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Automatic Algorithm - AutoVPAP With Addition of AutoEPAP | Treatment period with conventional device modified to enable algorithm for automatically applied Expiratory Positive Airway Pressure AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter |
Not provided
Not provided
Exclusion of patients whose fundamental disorder was sleep-disordered breathing with an incidental diagnosis of COPD or of OHS and only moderate obesity, and without other supporting evidence, turned out not to be practicable for all cases.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Helmut Teschler | Universitätsklinik, Essen | 0201 433 4001 | teschlerh@t-online.de |
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012891 | Sleep Apnea Syndromes |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D001049 | Apnea |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| AutoVPAP with EPAP manually selected | Device | Conventionally applied Expiratory Positive Airway Pressure (EPAP) |
|
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | count of participants |
|
| FEV1(%predicted) | Median | Inter-Quartile Range | %predicted |
|
| FEV1/FVC | Median | Inter-Quartile Range | % |
|
A period of treatment using conventionally applied Expiratory Positive Airway Pressure AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter during a single night of polysomnography following randomisation. |
|
|
| Secondary | Mean SpO2 | During sleep, pulse oximetery is recorded through a sensor on the participants finger | Posted | Mean | Standard Deviation | Percent | On completion of each night of 2 consecutive nights polysomnography. |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Conventional Therapy - AutoVPAP With EPAP Manually Selected | A period of treatment using conventionally applied Expiratory Positive Airway Pressure AutoVPAP: Implementation of automated algorithm for adjustment of conventional device parameter | 0 | 21 | 0 | 21 | 0 | 21 |
Not provided
Not provided
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |