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Asynchronies in NIV With External Gas

Trigger Asynchronies Induced by the Introduction of External Gas Into the Non-invasive Mechanical Ventilation Circuit: a Bench-to-bedside Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04884828
Enrollment
7
Registered
2021-05-13
Start date
2018-04-01
Completion date
2021-03-30
Last updated
2021-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-invasive Ventilation

Keywords

Non-invasive Ventilation, trigger asynchronies, autotriggering, bench study

Brief summary

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.

Interventions

DEVICEexternal gas during NIV

The procedure was performed in the patient's room during his or her hospital stay to avoid additional visits for study participation. The patient was placed in the supine position, and the usual ventilator interface was placed in a single-limb system, along with the commercial ventilator to be studied. The ventilator model were evaluated at bedside in random order. The parameters of the ventilator were the same as those that the patients used at home (that is, unlike the bench study, the sensitivity of the trigger was not modified). A external polygraph was used to moritor the study, with the incorporation of thoracic and abdominal bands and parasternal electromyography, to better evaluate asynchronies, in addition to pulse oximetry control. The ventilation periods were 1 minute (without gas, gas, without gas). This sequence was performed twice in each group of established conditions.

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Asynchronies ( yes or no)1 dayPresence of asynchronies identify by SOMNONIV´s algorithm during the gas treatment with NIV
Type of asynchronies1 dayautotrigger or innefective effort identify by SOMNONIV´s group algorithm, during the gas treatment with NIV

Secondary

MeasureTime frameDescription
Type of asynchronies pre1 dayautotrigger or innefectuve effort identify by SOMNONIV´s group pre gas during NIV treatment
Type of asynchronies post1 dayautotrigger or innefective effort identify by SOMNONIV´s group algorithm, , post gas during NIV
Asynchronies ( yes or no) pre1 dayPresence of asynchronies identify by SOMNONIV´s algorithm during pre-gas treatment with NIV
Asynchronies ( yes or no) post1 dayPresence of asynchronies identify by SOMNONIV´s algorithm during the post gas treatment with NIV

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026