Home Non-Invasive VentilationNCT04054570
The Geneva Lake Study Update : An Overview of Home Non-Invasive Ventilation 15 Years Later
An observational study of Home Non-Invasive Ventilation, run by University Hospital, Geneva.
Trial summary
A multicenter cross-sectional observational study was conducted in the counties of Geneva and Vaud (1'271'957 inhabitants in 2016 and 1'288'090 inhabitants in 2017 ) and included all subjects under home NIV followed by the two university hospitals of Geneva and Lausanne (HUG and CHUV), one private regional general… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Home Non-Invasive Ventilation
- How many people
- 947 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients of all age undergoing long term home NIV for at least 3 months and living in the Cantons of Geneva or Vaud
Who may be able to join
- All patients aged over 18 years old undergoing long term home NIV for at least 3 months and living in the Cantons of Geneva or Vaud were eligible for the study.
Who cannot join
- The only exclusion criteria was invasive ventilation (tracheostomy).
About this study
A multicenter cross-sectional observational study was conducted in the counties of Geneva and Vaud (1'271'957 inhabitants in 2016 and 1'288'090 inhabitants in 2017 ) and included all subjects under home NIV followed by the two university hospitals of Geneva and Lausanne (HUG and CHUV), one private regional general hospital (La Tour Hospital), one pulmonary rehabilitation center (Rolle Hospital) and 38 pulmonologists in private practice (for a total of 43, 18 in Geneva and 20 in Vaud). In Switzerland home NIV can be prescribed, initiated and followed by a pulmonologist in private practice without referring to a hospital center. The coordinating institution for this project was the Geneva University Hospital (HUG).
The investigator's goals were to update the prevalence of home NIV, the description of the population involved, the devices used, their settings, compliance, and a large array of technical data to provide a complete photography of home NIV in an area with 30 years of experience in this field. We also aimed to collect data regarding pursuit or interruption of NIV and survival during observation period.
- Conditions
- Home Non-Invasive Ventilation
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Adaptive servo-ventilation patients | All patients under adaptive servo-ventilation in the Geneva Lake area and details of the specifics indications, population treated and venitator settings Receives: Other: No intervention | |
| Barometric and Volumetric patients | All patients under barometric and volumetric ventilation in the Geneva Lake area and details of the specifics indications, population treated and venitator settings Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis
Diagnosis leading to NIV. 5 disease categories with identification of the percentage of patients with SRBD, COPD, Overlap syndrome, OHS, NMD, restrictive chest wall and lung disorders. All data were analyzed using descriptive statistics. Qualitative parameters were described as frequencies and percentages and quantitative parameters were described as mean and standard deviation (SD) or as median and interval interquartile (IQR). Comparisons between groups were performed using chi-square tests or Fisher exact tests for qualitative parameters and analysis of variance (one-way ANOVA) or Kruskal-Wallis tests for quantitative parameters, as appropriate.
Measured: 01.06.2016-10.07.2018
Secondary outcomes (9)
Baseline characteristics
Comorbidities, age, gender. All data were analyzed using descriptive statistics. Qualitative parameters were described as frequencies and percentages and quantitative parameters were described as mean and standard deviation (SD) or as median and interval interquartile (IQR). Comparisons between groups were performed using chi-square tests or Fisher exact tests for qualitative parameters and analysis of variance (one-way ANOVA) or Kruskal-Wallis tests for quantitative parameters, as appropriate.
Measured: 01.06.2016-10.07.2018
Survival
Analyze short-term mortality rate and risk factors. All data were analyzed using descriptive statistics. Qualitative parameters were described as frequencies and percentages and quantitative parameters were described as mean and standard deviation (SD) or as median and interval interquartile (IQR). Comparisons between groups were performed using chi-square tests or Fisher exact tests for qualitative parameters and analysis of variance (one-way ANOVA) or Kruskal-Wallis tests for quantitative parameters, as appropriate.
Measured: 01.06.2016-01.05.2021
Leaks
Investigate modifiable and non-modifiable risk factors asssociated with non intentional air leaks during home non invasive ventilation (NIV). Air leaks are identified by the built in software of the ventilator and clinicians download these data onto a computer. Leaks are expressed in ml or liters. All data were analyzed using descriptive statistics. Qualitative parameters were described as frequencies and percentages and quantitative parameters were described as mean and standard deviation (SD) or as median and interval interquartile (IQR). Comparisons between groups were performed using chi-square tests or Fisher exact tests for qualitative parameters and analysis of variance (one-way ANOVA) or Kruskal-Wallis tests for quantitative parameters, as appropriate.
Measured: 01.06.2016-10.07.2018
Implementation of NIV
Is NIV implemented electively or urgently (yes versus no), in an outpatient or input setting (yes vs no), by liberal pulmonologist or hospital center (yes vs no). Data with binary outcome. All data were analyzed using descriptive statistics. Qualitative parameters were described as frequencies and percentages and quantitative parameters were described as mean and standard deviation (SD) or as median and interval interquartile (IQR). Comparisons between groups were performed using chi-square tests or Fisher exact tests for qualitative parameters and analysis of variance (one-way ANOVA) or Kruskal-Wallis tests for quantitative parameters, as appropriate.
Measured: 01.06.2016-10.07.2018
Follow-up modalities
Arterial blood gas (ABG): pH, pCO2 (kPa), pO2 (kPa), HCO3 (mmol/l), base excess (mmol/l), SpO2 (%), spirometry: FEV1/FVC % of predicted, FEV1 % of predicted, FVC % of predicted, pulsoxicapnometry: SpO2 (%), time with SpO2 < 90% (%), desaturation index > 3 (%), pCO2 (kPa). All data were analyzed using descriptive statistics. Qualitative parameters were described as frequencies and percentages and quantitative parameters were described as mean and standard deviation (SD) or as median and interval interquartile (IQR). Comparisons between groups were performed using chi-square tests or Fisher exact tests for qualitative parameters and analysis of variance (one-way ANOVA) or Kruskal-Wallis tests for quantitative parameters, as appropriate.
Measured: 01.06.2016-10.07.2018
Ventilators
Home ventilators used (ASV vs barometric vs volumetric), settings: minimal and maximal pressure support (cmH2O), fixed EPAP (cmH20), minimal and maximal EPAP (cmH2O), back-up respiratory rate (cycles/min), data downloaded from the device software: EPAP (cmH2O), IPAP (cmH2O), EPAP 90% (cmH2O), mean pressure support (cmH2O), tidal volume (ml), minute ventilation (L/min), leaks (L/min), apnea index (N/hour), apnea-hypopnea index (N/hour), mean daily use (min/day), interfaces (facial vs nasal vs prongs masks), duration to therapy (expressed in hours). All data were analyzed using descriptive statistics. Qualitative parameters were described as frequencies and percentages and quantitative parameters were described as mean and standard deviation (SD) or as median and interval interquartile (IQR).
Measured: 01.06.2016-10.07.2018
Prevalence of home non invasive ventilation (NIV)
Prevalence of home non invasive ventilation. All data were analyzed using descriptive statistics. Qualitative parameters were described as frequencies and percentages and quantitative parameters were described as mean and standard deviation (SD) or as median and interval interquartile (IQR). Comparisons between groups were performed using chi-square tests or Fisher exact tests for qualitative parameters and analysis of variance (one-way ANOVA) or Kruskal-Wallis tests for quantitative parameters, as appropriate.
Measured: 01.06.2016-10.07.2018
Barometric and volumetric ventilation versus adaptive servo-ventilation (ASV)
Sub-analysis groups depending on the type of home NIV (barometric and volumetric ventilation versus ASV). All data were analyzed using descriptive statistics. Qualitative parameters were described as frequencies and percentages and quantitative parameters were described as mean and standard deviation (SD) or as median and interval interquartile (IQR). Comparisons between groups were performed using chi-square tests or Fisher exact tests for qualitative parameters and analysis of variance (one-way ANOVA) or Kruskal-Wallis tests for quantitative parameters, as appropriate.
Measured: 01.06.2016-10.07.2018
Medical follow-up
To study if there is a statistical significance in the outcomes listed above (diagnostic groups, comorbidities) depending if the medical follow-up is done by a liberal pulmonologist or a hospital center. All data were analyzed using descriptive statistics. Qualitative parameters were described as frequencies and percentages and quantitative parameters were described as mean and standard deviation (SD) or as median and interval interquartile (IQR). Comparisons between groups were performed using chi-square tests or Fisher exact tests for qualitative parameters and analysis of variance (one-way ANOVA) or Kruskal-Wallis tests for quantitative parameters, as appropriate.
Measured: 01.06.2016-10.07.2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Jun 2016
- Primary completion10 Jul 2018
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Home Non-Invasive VentilationStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 947 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Paul Janssens, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054570
- Sponsor's protocol ID
- n°PB_2016-00925/15-275
- Status last verified
- Oct 2021
- First submitted
- 21 Jul 2019
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Janssens JP, Derivaz S, Breitenstein E, De Muralt B, Fitting JW, Chevrolet JC, Rochat T. Changing patterns in long-term noninvasive ventilation: a 7-year prospective study in the Geneva Lake area. Chest. 2003 Jan;123(1):67-79. doi: 10.1378/chest.123.1.67.
PubMed 12527605Cantero C, Adler D, Pasquina P, Uldry C, Egger B, Prella M, Younossian AB, Poncet A, Soccal-Gasche P, Pepin JL, Janssens JP. Adaptive Servo-Ventilation: A Comprehensive Descriptive Study in the Geneva Lake Area. Front Med (Lausanne). 2020 Apr 3;7:105. doi: 10.3389/fmed.2020.00105. eCollection 2020.
PubMed 32309284Cantero C, Adler D, Pasquina P, Uldry C, Egger B, Prella M, Younossian AB, Soccal PM, Pepin JL, Janssens JP. Long-Term Noninvasive Ventilation in the Geneva Lake Area: Indications, Prevalence, and Modalities. Chest. 2020 Jul;158(1):279-291. doi: 10.1016/j.chest.2020.02.064. Epub 2020 Mar 31.
PubMed 32243941
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Geneva Lake Study Update : An Overview of Home Non-Invasive Ventilation 15 Years Later
- ClinicalTrials.gov ID
- NCT04054570
- Acronym / sponsor ID
- n°PB_2016-00925/15-275
- Conditions
- Home Non-Invasive Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 947 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter cross-sectional observational study was conducted in the counties of Geneva and Vaud (1'271'957 inhabitants in 2016 and 1'288'090 inhabitants in 2017 ) and included all subjects under home NIV followed by the two university hospitals of Geneva and Lausanne (HUG and CHUV), one private regional general hospital (La Tour Hospital), one pulmonary rehabilitation center (Rolle Hospital) and 38 pulmonologists in private practice (for a total of 43, 18 in Geneva and 20 in Vaud). In Switzerland home NIV can be prescribed, initiated and followed by a pulmonologist in private practice without referring to a hospital center. The coordinating institution for this project was the Geneva University Hospital (HUG).
The investigator's goals were to update the prevalence of home NIV, the description of the population involved, the devices used, their settings, compliance, and a large array of technical data to provide a complete photography of home NIV in an area with 30 years of experience in this field. We also aimed to collect data regarding pursuit or interruption of NIV and survival during observation period.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive servo-ventilation patients | – | Other: No interventionAll patients under adaptive servo-ventilation in the Geneva Lake area and details of the specifics indications, population treated and venitator settings |
| Barometric and Volumetric patients | – | Other: No interventionAll patients under barometric and volumetric ventilation in the Geneva Lake area and details of the specifics indications, population treated and venitator settings |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of all age undergoing long term home NIV for at least 3 months and living in the Cantons of Geneva or Vaud
Key inclusion criteria (1 listed)
- All patients aged over 18 years old undergoing long term home NIV for at least 3 months and living in the Cantons of Geneva or Vaud were eligible for the study.
Key exclusion criteria (1 listed)
- The only exclusion criteria was invasive ventilation (tracheostomy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo Intervention | Other | Adaptive servo-ventilation patients, Barometric and Volumetric patients |
Primary outcome
Diagnosis
Time frame: 01.06.2016-10.07.2018
Diagnosis leading to NIV. 5 disease categories with identification of the percentage of patients with SRBD, COPD, Overlap syndrome, OHS, NMD, restrictive chest wall and lung disorders. All data were analyzed using descriptive statistics. Qualitative parameters were described as frequencies and percentages and quantitative parameters were described as mean and standard deviation (SD) or as median and interval interquartile (IQR). Comparisons between groups were performed using chi-square tests or Fisher exact tests for qualitative parameters and analysis of variance (one-way ANOVA) or Kruskal-Wallis tests for quantitative parameters, as appropriate.
9 secondary outcomes
Baseline characteristics
Time frame: 01.06.2016-10.07.2018
Survival
Time frame: 01.06.2016-01.05.2021
Leaks
Time frame: 01.06.2016-10.07.2018
Implementation of NIV
Time frame: 01.06.2016-10.07.2018
Follow-up modalities
Time frame: 01.06.2016-10.07.2018
Ventilators
Time frame: 01.06.2016-10.07.2018
Prevalence of home non invasive ventilation (NIV)
Time frame: 01.06.2016-10.07.2018
Barometric and volumetric ventilation versus adaptive servo-ventilation (ASV)
Time frame: 01.06.2016-10.07.2018
Medical follow-up
Time frame: 01.06.2016-10.07.2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Results publication: PubMed 12527605Janssens JP, Derivaz S, Breitenstein E, De Muralt B, Fitting JW, Chevrolet JC, Rochat T. Changing patterns in long-term noninvasive ventilation: a 7-year prospective study in the Geneva Lake area. Chest. 2003 Jan;123(1):67-79. doi: 10.1378/chest.123.1.67.
- Derived from this study: PubMed 32309284Cantero C, Adler D, Pasquina P, Uldry C, Egger B, Prella M, Younossian AB, Poncet A, Soccal-Gasche P, Pepin JL, Janssens JP. Adaptive Servo-Ventilation: A Comprehensive Descriptive Study in the Geneva Lake Area. Front Med (Lausanne). 2020 Apr 3;7:105. doi: 10.3389/fmed.2020.00105. eCollection 2020.
- Derived from this study: PubMed 32243941Cantero C, Adler D, Pasquina P, Uldry C, Egger B, Prella M, Younossian AB, Soccal PM, Pepin JL, Janssens JP. Long-Term Noninvasive Ventilation in the Geneva Lake Area: Indications, Prevalence, and Modalities. Chest. 2020 Jul;158(1):279-291. doi: 10.1016/j.chest.2020.02.064. Epub 2020 Mar 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Home Non-Invasive Ventilation, run by University Hospital, Geneva.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis (time frame: 01.06.2016-10.07.2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04054570, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.