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.

Study Overview

• Status: Completed
• Conditions: Home Non-Invasive Ventilation
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 947

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: No intervention; 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	Other: No intervention; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	01.06.2016-10.07.2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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).	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.	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.	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.	01.06.2016-10.07.2018

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Publications and helpful links

General 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.
• Cantero 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.
• Cantero 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): July 10, 2018
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: July 21, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 31, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: n°PB_2016-00925/15-275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No