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Completed

NCT Number: NCT04054570

The Geneva Lake Study Update : An Overview of Home Non-Invasive Ventilation 15 Years Later

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • The only exclusion criteria was invasive ventilation (tracheostomy).

Treatment and study plan

No intervention

Other

No Intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Baseline characteristics

    Time frame: 01.06.2016-10.07.2018

    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.

  2. Survival

    Time frame: 01.06.2016-01.05.2021

    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.

  3. Leaks

    Time frame: 01.06.2016-10.07.2018

    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.

  4. Implementation of NIV

    Time frame: 01.06.2016-10.07.2018

    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.

  5. Follow-up modalities

    Time frame: 01.06.2016-10.07.2018

    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.

  6. Ventilators

    Time frame: 01.06.2016-10.07.2018

    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).

  7. Prevalence of home non invasive ventilation (NIV)

    Time frame: 01.06.2016-10.07.2018

    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.

  8. Barometric and volumetric ventilation versus adaptive servo-ventilation (ASV)

    Time frame: 01.06.2016-10.07.2018

    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.

  9. Medical follow-up

    Time frame: 01.06.2016-10.07.2018

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2021
First posted
Aug 13, 2019
Registry last updated
Nov 8, 2021

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.