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NCT04884828 Clinical Trial

Asynchronies in NIV With External Gas

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

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date May 2021
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• external 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.

Locations
Country Name City State
Spain Cristina Lalmolda Sabadell Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome
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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