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| ID | Type | Description | Link |
|---|---|---|---|
| R&D No. 2008/LF017B | Other Identifier | Research & Development Department, RBH |
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| Name | Class |
|---|---|
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
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.
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients newly diagnosed with nocturnal hypoventilation who are inexperienced in the use of noninvasive ventilation (NIV). NIV is standard therapy for patients with nocturnal hypoventilation.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 referred to, or under follow up at, the Royal Brompton Hospital who require domiciliary NIV but are inexperienced with use of NIV will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. At the end of one month the patient will be swapped to the alternative NIV for a further one month of domiciliary NIV treatment. At the end of each one month treatment period the patient will undergo overnight polysomnography, transcutaneous CO2 monitoring and 24 hour Holter monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autotitrating NIV | Experimental | approximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation |
|
| Standard non-invasive ventilation | Active Comparator | approximately 6 weeks using domiciliary nocturnal standard non-invasive ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AutoVPAP | Device | Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. |
| Measure | Description | Time Frame |
|---|---|---|
| Overnight Mean Oxygen Saturation | Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overnight Mean Transcutaneous Carbon Dioxide | Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. | 4 weeks |
| Overnight Peak Transcutaneous Carbon Dioxide |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator Adherence | Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak). | 4 weeks |
| Median Overnight Minute Ventilation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anita Simonds, MD, FRCP | Royal Brompton & Harefield Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | AutoVPAP Then VPAPIIIST-A | All patients underwent a cross over design - 1 month using domiciliary nocturnal standard non-invasive ventilation. (VPAPIIIST-A), and one month using AutoTitrating non-invasive ventilation |
| FG001 | VPAPIIIST-A First, Then AutoVPAP | All patients underwent a cross over design - 1 month using domiciliary nocturnal standard non-invasive ventilation. (VPAPIIIST-A), and one month using AutoTitrating non-invasive ventilation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Patients underwent a cross over study design. In a randomised order they used 1 month of domiciliary nocturnal autotitrating, intelligent volume assured pressure support (iVAPS) non-invasive ventilation, and one month of standard non-invasive ventilation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Overnight Mean Oxygen Saturation | Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. | Posted | Median | Inter-Quartile Range | % SaO2 | 4 weeks |
|
Adverse events were monitored over the entire course of the trial; each participant was monitored throughout their participation of 2 months (1 month on each ventilator).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Autotitrating iVAPS NIV | AutoVPAP: Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of iVAPS NIV therapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miss Julia Kelly | Royal Brompton Hospital | +44 2073528121 | 4183 | j.kelly@rbht.nhs.uk |
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| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D012131 | Respiratory Insufficiency |
| D006935 | Hypercapnia |
| D007040 | Hypoventilation |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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| VPAPIIIST-A | Device | Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. |
|
|
Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. |
| 4 weeks |
| Oxygen Desaturation Index (>4%) | Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. ODI is the number of events per hour that SaO2 drops by >4%. | 4 weeks |
| Sleep Quality: Arousal Index | A full PSG was performed during a sleep a on NIV at the end of each month's NIV therapy. Standard polysomnography analysis was performed by two team members blinded to patient identity and ventilator mode (REP/JJ). Sleep quality was assessed by the Arousal Index (no of arousals/hour) | 4 weeks |
Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak). |
| 4 weeks |
| Median Overnight Pressure Support | Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak). | 4 weeks |
| Median Overnight Tidal Volume | Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak). | 4 weeks |
| Median Overnight Respiratory Rated | Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak). | 4 weeks |
| Subjective Ventilator Tolerance: Comfort of Breath Delivered | Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive) | 4 weeks |
| Subjective Ventilator Tolerance: Ease of Falling Asleep | Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive) | 4 weeks |
| Subjective Ventilation Tolerance: Ease of Use of Ventilator | Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive) | 4 weeks |
| Subjective Ventilator Tolerance: Liked Using Ventilator | Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive) | 4 weeks |
| Ventilator Mode Preference | Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive) | 4 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| FEV1 (forced expiratory volume) (L) | Median | Inter-Quartile Range | L |
|
| FVC (forced vital capacity) | Median | Inter-Quartile Range | L |
|
| FEV1/FVC | Median | Inter-Quartile Range | ratio |
|
| maximal inspiratory effort (MIP) (cmH2O) | Median | Inter-Quartile Range | cmH2O |
|
| Maximum expiratory pressure (MEP) | Median | Inter-Quartile Range | cmH2O |
|
| sniff nasal inspiratory pressure (SNIP) | Median | Inter-Quartile Range | cmH2O |
|
VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home.
All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy.
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| Secondary | Overnight Mean Transcutaneous Carbon Dioxide | Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. | All patients had a sleep study after 1 month of each mode of ventilation and all results are included in this analysis | Posted | Median | Inter-Quartile Range | kPa | 4 weeks |
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| Secondary | Overnight Peak Transcutaneous Carbon Dioxide | Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. | All patients had a sleep study after 1 month of each mode of ventilation and all results are included in this analysis | Posted | Median | Inter-Quartile Range | kPa | 4 weeks |
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| Secondary | Oxygen Desaturation Index (>4%) | Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. ODI is the number of events per hour that SaO2 drops by >4%. | All patients had a sleep study after 1 month of each mode of ventilation and all results are included in this analysis | Posted | Median | Inter-Quartile Range | events/hr | 4 weeks |
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| Secondary | Sleep Quality: Arousal Index | A full PSG was performed during a sleep a on NIV at the end of each month's NIV therapy. Standard polysomnography analysis was performed by two team members blinded to patient identity and ventilator mode (REP/JJ). Sleep quality was assessed by the Arousal Index (no of arousals/hour) | 16 patients had comparative PSG data with all signals present for their sleep studies on both ventilator modes. | Posted | Median | Inter-Quartile Range | events/hour | 4 weeks |
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| Other Pre-specified | Ventilator Adherence | Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak). | 1 participant had missing adherence data and so was excluded from this analysis | Posted | Median | Inter-Quartile Range | hh:mm/day | 4 weeks |
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| Other Pre-specified | Median Overnight Minute Ventilation | Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak). | 2 patients had missing values from one of the ventilator modes, thus were excluded from the analysis | Posted | Median | Inter-Quartile Range | L/min | 4 weeks |
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| Other Pre-specified | Median Overnight Pressure Support | Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak). | 2 patients had missing data from one of the ventialtory modes and were excluded from the analysis | Posted | Median | Inter-Quartile Range | cmH2O | 4 weeks |
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| Other Pre-specified | Median Overnight Tidal Volume | Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak). | 2 patients had missing data from one of the ventilatory modes and so were excluded | Posted | Median | Inter-Quartile Range | ml | 4 weeks |
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| Other Pre-specified | Median Overnight Respiratory Rated | Summary data from the ventilators were downloaded after each month's therapy, including adherence (hours of use), and ventilator output (nightly mean pressure support, minute ventilation (MV), RR and leak). | 2 patients had missing data from one ventilatory mode and thus were excluded from analysis | Posted | Median | Inter-Quartile Range | bpm | 4 weeks |
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| Other Pre-specified | Subjective Ventilator Tolerance: Comfort of Breath Delivered | Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive) | 2 patients had missing data and thus were excluded from analysis | Posted | Median | Inter-Quartile Range | units on a scale | 4 weeks |
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| Other Pre-specified | Subjective Ventilator Tolerance: Ease of Falling Asleep | Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive) | 2 patients had missing data and so were excluded from analysis | Posted | Median | Inter-Quartile Range | units on a scale | 4 weeks |
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| Other Pre-specified | Subjective Ventilation Tolerance: Ease of Use of Ventilator | Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive) | 2 patients had missing data and were thus excluded from analysis | Posted | Median | Inter-Quartile Range | units on a scale | 4 weeks |
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| Other Pre-specified | Subjective Ventilator Tolerance: Liked Using Ventilator | Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive) | 2 patients had missing data, thus were excluded from analysis | Posted | Median | Inter-Quartile Range | units on a scale | 4 weeks |
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| Other Pre-specified | Ventilator Mode Preference | Subjective tolerance of ventilator modes was assessed by 10cm visual analogue scales (VAS) in response to questions on comfort of breath, ease of falling asleep, use of ventilator, and mode preference. VAS was scored from 0-100 for each question (0 - negative and 100 -s positive) | Not Posted | 4 weeks | Participants |
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Standard Non-invasive PS Ventilation | VPAPIIIST-A: Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. All completing patients used iVAPS in either period1 or period 2. The results are for all patients after the 1 month of standard PS NIV therapy. | 0 | 23 | 0 | 23 | 0 | 23 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |