Non-invasive Ventilation Clinical Trial
Official title:
Trigger Asynchronies Induced by the Introduction of External Gas Into the Non-invasive Mechanical Ventilation Circuit: a Bench-to-bedside Study
NCT number | NCT04884828 |
Other study ID # | gasNIV |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2018 |
Est. completion date | March 30, 2021 |
Verified date | May 2021 |
Source | Corporacion Parc Tauli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
NIV can be combined with other treatments that require to introduce gas into the circuit during the treatment. This external gas produces trigger asynchronies that worse depending on the model ventilator, trigger design and gas source. It is advisable to monitor NIV when these treatments are requiring in chronic NIV.
Status | Completed |
Enrollment | 7 |
Est. completion date | March 30, 2021 |
Est. primary completion date | March 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - over 18 years of age, - hospital admission for acute chronic respiratory failure, - home NIV (single-limb system with intentional leakage) users for more than 6 months with adequate compliance (greater than or equal to 5 hours/night). Exclusion Criteria: - Patients with underlying psychiatric disease were excluded |
Country | Name | City | State |
---|---|---|---|
Spain | Cristina Lalmolda | Sabadell | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Corporacion Parc Tauli |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Asynchronies ( yes or no) | Presence of asynchronies identify by SOMNONIV´s algorithm during the gas treatment with NIV | 1 day | |
Primary | Type of asynchronies | autotrigger or innefective effort identify by SOMNONIV´s group algorithm, during the gas treatment with NIV | 1 day | |
Secondary | Type of asynchronies pre | autotrigger or innefectuve effort identify by SOMNONIV´s group pre gas during NIV treatment | 1 day | |
Secondary | Type of asynchronies post | autotrigger or innefective effort identify by SOMNONIV´s group algorithm, , post gas during NIV | 1 day | |
Secondary | Asynchronies ( yes or no) pre | Presence of asynchronies identify by SOMNONIV´s algorithm during pre-gas treatment with NIV | 1 day | |
Secondary | Asynchronies ( yes or no) post | Presence of asynchronies identify by SOMNONIV´s algorithm during the post gas treatment with NIV | 1 day |
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