NCT04054570

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
947

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 21, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 13, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

2.1 years

First QC Date

July 21, 2019

Last Update Submit

October 31, 2021

Conditions

Home Non-Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Baseline characteristics

    01.06.2016-10.07.2018

  • Survival

    01.06.2016-01.05.2021

  • Leaks

    01.06.2016-10.07.2018

  • Implementation of NIV

    01.06.2016-10.07.2018

  • Follow-up modalities

    01.06.2016-10.07.2018

  • +4 more secondary outcomes

Study Arms (2)

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

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

Interventions

No interventionOTHER

No Intervention

Adaptive servo-ventilation patientsBarometric and Volumetric patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 12527605RESULT

  • 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.

    PMID: 32309284DERIVED

  • 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.

    PMID: 32243941DERIVED

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Jean-Paul Janssens

Study Record Dates

First Submitted

July 21, 2019

First Posted

August 13, 2019

Study Start

June 1, 2016

Primary Completion

July 10, 2018

Study Completion

May 1, 2021

Last Updated

November 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share